<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03040011</url>
  </required_header>
  <id_info>
    <org_study_id>PRO16110378</org_study_id>
    <nct_id>NCT03040011</nct_id>
  </id_info>
  <brief_title>Preoperative Levator Ani Muscle Injection and Pudendal Nerve Block for Pain Control After Vaginal Reconstructive Surgery</brief_title>
  <official_title>Preoperative Levator Ani Muscle Injection and Pudendal Nerve Block With Bupivacaine and Dexamethasone for Improved Pain Control After Vaginal Reconstructive Surgery: A Three-Arm Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lauren Giugale, MD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Magee-Womens Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Pittsburgh</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      To test the hypothesis that preoperative injections along the levator ani muscles and&#xD;
      pudendal nerve with bupivacaine and dexamethasone improve pain control after vaginal apical&#xD;
      reconstructive surgery. A three-arm, double-blinded, randomized controlled trial of a total&#xD;
      of 75 women will be performed.&#xD;
&#xD;
      The study population will be adult women (&gt;18 years of age) with uterovaginal or vaginal&#xD;
      vault prolapse who have been scheduled for native tissue vaginal reconstructive surgery which&#xD;
      includes an apical support procedure. Participants will be enrolled prior to surgery. The&#xD;
      procedure will involved four injection sites: the bilateral levator ani muscles via a&#xD;
      transobturator approach and bilateral pudendal nerves via a transvaginal approach. Random&#xD;
      assignment will occur to one of three study arms: combined arm (20 milliliters&#xD;
      bupivacaine/dexamethasone solution divided between the 4 injection sites), bupivacaine arm&#xD;
      (20 milliliters bupivacaine divided between the 4 injection sites), or placebo arm (20&#xD;
      milliliters saline divided between the 4 injection sites).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary purpose of this three arm, randomized clinical trial is to test the hypothesis&#xD;
      that preoperative injections along the levator ani muscles and pudendal nerve with&#xD;
      bupivacaine and dexamethasone improve pain control after vaginal native tissue apical&#xD;
      reconstructive surgery.&#xD;
&#xD;
      Hypothesis: concurrent bilateral transobturator levator ani muscle injections and&#xD;
      transvaginal pudendal nerve blocks with bupivacaine and dexamethasone performed prior to&#xD;
      vaginal apical support procedures will result in improved pain scores at 24 hours&#xD;
      postoperatively.&#xD;
&#xD;
      Participants will be randomized to three arms: bupivacaine/dexamethasone group, bupivacaine&#xD;
      group, and placebo group. Block randomization will occur and will be stratified by surgery&#xD;
      type to ensure that similar numbers of each procedure are randomized to each study arm.&#xD;
&#xD;
      All 3 groups will receive pudendal nerve blocks and transobturator levator ani muscle&#xD;
      injections as outlined in detail below (with either bupivacaine/dexamethasone, bupivacaine&#xD;
      alone or saline depending on randomization). The interventions will be performed after the&#xD;
      participant is positioned in lithotomy position and after sterile preparation of the vagina&#xD;
      and perineum per standard protocol. These injections will be performed at the start of the&#xD;
      procedure prior to any vaginal repair and be administered by either the attending surgeon or&#xD;
      the urogynecology fellow. After the interventions below, the vaginal reconstructive&#xD;
      procedures will be performed as usual by the attending surgeon and surgical team. There are&#xD;
      both fellows and residents who participate in these vaginal reconstructive surgeries, however&#xD;
      for study purposes, resident physicians will not be permitted to administer either the&#xD;
      pudendal nerve block or the transobturator injections. There are four attending surgeons and&#xD;
      four fellow physicians who will be administering the injections. While all surgeons are&#xD;
      familiar with the anatomy and have performed these procedures, each physician will be&#xD;
      instructed on the intended procedures and additionally will be directly observed in the&#xD;
      operating room for at least one procedure to ensure consistency in technique. All&#xD;
      participants will undergo a standardized general anesthesia regimen.&#xD;
&#xD;
      After the study intervention, all participants will then undergo the scheduled vaginal&#xD;
      reconstructive procedure as standard. Infiltration of the vaginal epithelium with lidocaine&#xD;
      is common in vaginal repairs. The maximum doses of lidocaine and bupivacaine are additive.&#xD;
      The amount of local infiltration to 50 milliliters of 0.5% lidocaine with epinephrine. This&#xD;
      dose is equal to 250mg of lidocaine which, when also taking into account the 50mg of&#xD;
      bupivacaine, is within a safe dosing range for a participant weighing 50kg.&#xD;
&#xD;
      Administration of all four injections involved in the study protocol and described above take&#xD;
      approximately 5 additional minutes in total at the start of the case. After the injections&#xD;
      are performed, there will be no further interventions.&#xD;
&#xD;
      Other assessments that will be performed as part of the study protocol are outlined below:&#xD;
&#xD;
      Baseline assessments: Pain assessment, assessment of presence of any baseline nausea or&#xD;
      vomiting, baseline activities assessment will all be performed in preoperative area on the&#xD;
      day of surgery prior to randomization.&#xD;
&#xD;
      Postoperative pain score assessment: 3 hours, 24 hours, 48 hours, 72 hours, and 1 week&#xD;
      postoperatively. Postoperative pain measured by the numerical rating scale (NRS). The NRS is&#xD;
      a publicly available pain assessment tool that consists of an eleven point scale ranging from&#xD;
      0 to 10 (0 = no pain and 10 = worst possible pain) presented visually on a horizontal line.&#xD;
      Participants are asked to report a number or mark on the scale. Previous studies have&#xD;
      demonstrated its reliability, validity and ease of administration. The NRS was chosen because&#xD;
      a systematic review article demonstrated higher compliance rates, better responsiveness and&#xD;
      ease of use relative to visual analog scales. Additionally, the NRS has been shown to have&#xD;
      strong validity and low error rates when used in an elderly (&gt;60 years) postoperative patient&#xD;
      population.&#xD;
&#xD;
      Postoperative nausea and vomiting assessment: 3 hours postoperatively The intensity of&#xD;
      postoperative nausea and vomiting (PONV) using the PONV Intensity scale. The PONV scale is a&#xD;
      four question assessment designed to measure clinically significant nausea and vomiting. It&#xD;
      was initially validated in a general surgery population and has been validated in early&#xD;
      postoperative gynecology patients. Clinically important nausea and vomiting is defined as a&#xD;
      score greater than or equal to 50. This scale takes approximately 1 minute to complete and is&#xD;
      publicly available. The amount of inpatient anti-emetic consumption will also be assessed.&#xD;
      Any anti-emetic administered from surgery end time will be recorded as well as the dosage.&#xD;
      Anti-emetic type and dosage will be recorded until the time of discharge.&#xD;
&#xD;
      Voiding status at time of foley catheter removal. All patients routinely have some assessment&#xD;
      of voiding function prior to discharge. Whether each participant passed or failed a voiding&#xD;
      trial after surgery will be recorded in the database. If a participant fails, the standard of&#xD;
      care is do be discharged to home after learning self-catheterization or with a foley&#xD;
      catheter. In the event that a participant fails a postoperative voiding trial, whether&#xD;
      participants receive a foley catheter or were performing self-catheterization will be&#xD;
      recorded. As this is a routine part of postoperative care, the research protocol will not&#xD;
      interfere with the performance or outcomes of a voiding trial. Results will be documented,&#xD;
      however no specific assessment tool will be used.&#xD;
&#xD;
      Time to resume normal activities measured by the activities assessment scale (AAS): 1 week, 2&#xD;
      weeks, 6 weeks and 12 weeks postoperatively The AAS was initially designed to assess&#xD;
      functional activity in the perioperative period in the general surgery population. It has&#xD;
      since been deemed a valid and reliable measure to assess postoperative activity level in a&#xD;
      Female Pelvic Medicine and Reconstructive Surgery patient population. It has the ability to&#xD;
      measure perioperative function and takes approximately 3-5 minutes to complete. It consists&#xD;
      of a 13 item questionnaire assessing various types of physical activity and the degree of&#xD;
      difficulty associated with each activity. The types of activities assessed fall into three&#xD;
      subscales: sedentary activities (questions 1-4), ambulatory activities (questions 6-8), and&#xD;
      work or exercise activities (questions 11-13). Respondents also have the option to indicate&#xD;
      that these activities were not performed for another indication (this item is not scored).&#xD;
      The time frame for all questions is the previous 24 hours. Given that many patients are&#xD;
      instructed to avoid strenuous work or exercise activity in the postoperative period, the&#xD;
      subscales of sedentary activities and ambulatory activities, which patients are encouraged to&#xD;
      perform as tolerated in the postoperative period, will be of most interest.&#xD;
&#xD;
      Consumption of analgesic medications: during inpatient hospital stay and for first 72 hours&#xD;
      postoperatively Narcotic consumption will be measured in morphine equivalents. The amount of&#xD;
      narcotics will be obtained from the inpatient hospital record. All narcotics received from&#xD;
      the surgery end time to the time of discharge will be included. Morphine equivalents will be&#xD;
      calculated with online calculator available at&#xD;
      http://www.agencymeddirectors.wa.gov/Calculator/DoseCalculator.htm. Similarly, the amount of&#xD;
      NSAIDs will be obtained from the inpatient hospital record. All NSAIDs received from the&#xD;
      surgery end time to the time of discharge will be included. To assess both the amount of&#xD;
      narcotic and NSAID consumption after discharge, the participant will be provided with a diary&#xD;
      form to record how many daily tablets of narcotic and NSAIDs are taken. This form will be&#xD;
      completed from postoperative days 1-3.&#xD;
&#xD;
      For all forms, the participants will be instructed to mail the forms back to the office once&#xD;
      completed (in a pre-address envelope provided as part of the study). Participants will also&#xD;
      have the option of brining the forms in to the office at the time of a participant's&#xD;
      postoperative visit.&#xD;
&#xD;
      Participants, physicians and any nursing personnel involved in patient care will remain&#xD;
      masked until 12 weeks postoperatively.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2017</start_date>
  <completion_date type="Actual">August 5, 2019</completion_date>
  <primary_completion_date type="Actual">April 11, 2019</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Three-arm, double-blinded, placebo-controlled, randomized controlled trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Double-blinded</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Primary Postoperative Pain Measured by the Numerical Rating Scale (NRS)</measure>
    <time_frame>24 hours postoperatively</time_frame>
    <description>Postoperative pain measured by the numerical rating scale (NRS) at 24 hours postoperatively. The Numeric Rating Scale is an 11 point scale ranging from 0-10 with higher scores indicating worse pain.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>6 Hour Postoperative Pain Measured by the NRS</measure>
    <time_frame>6 hours postoperatively</time_frame>
    <description>Postoperative pain as measured by the NRS at 6 hours after surgery. The Numeric Rating Scale is an 11 point scale ranging from 0-10 with higher scores indicating worse pain.&#xD;
Of note, there is a typographical error in the protocol section and refers to this outcome as a NRS score at 3 hours postoperatively. The final IRB approved protocol is a 6 hour postoperative timepoint and this is the correct outcome reported here in the results section.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>POD 2 Postoperative Pain Measured by the NRS</measure>
    <time_frame>2 days after surgery</time_frame>
    <description>Postoperative Pain Measured by the NRS 2 days after surgery. The Numeric Rating Scale is an 11 point scale ranging from 0-10 with higher scores indicating worse pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>POD 3 Postoperative Pain Measured by the NRS</measure>
    <time_frame>3 days after surgery</time_frame>
    <description>Postoperative Pain Measured by the NRS 3 days after surgery. The Numeric Rating Scale is an 11 point scale ranging from 0-10 with higher scores indicating worse pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>1 Week Postoperative Pain Measured by the NRS</measure>
    <time_frame>1 week after surgery</time_frame>
    <description>Postoperative Pain Measured by the Numeric Rating Scale 1 week after surgery. The Numeric Rating Scale is an 11 point scale ranging from 0-10 with higher scores indicating worse pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Patients With Same Day Discharge</measure>
    <time_frame>Day of surgery</time_frame>
    <description>Same day discharge was defined as a patient being discharged on the same day as surgery and did not require an admission after surgery. The proportion of patients who were discharged on the day of surgery was compared between groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative Urinary Retention</measure>
    <time_frame>0-24 hours postoperatively</time_frame>
    <description>Urinary retention was defined as the need to perform self-catheterization or have an indwelling catheter placed postoperatively. The proportion of patients with urinary retention was compared between groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse Events</measure>
    <time_frame>0-12 weeks postoperatively</time_frame>
    <description>The number of adverse events in each study group was assessed and compared between study groups. An adverse event was described as any medical or surgical complication that occurred either intraoperatively or postoperatively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nausea and Vomiting Measured by the PONV Scale</measure>
    <time_frame>6 hours postoperatively</time_frame>
    <description>Intensity of postoperative nausea and vomiting (PONV) measured by the PONV scale prior to discharge. The Postoperative Nausea and Vomiting Intensity Scale is a four-question assessment to measure clinically significant nausea and vomiting with a range from 0-7 with higher scores signifying more clinically significant nausea and vomiting.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anti-emetic Consumption</measure>
    <time_frame>3 hours postoperatively</time_frame>
    <description>The amount of inpatient anti-emetic consumption, recorded in number of doses of nausea medication</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Return to Baseline Activities Using the Activities Assessment Scale</measure>
    <time_frame>1 week postoperative</time_frame>
    <description>Resumed normal daily activities using the Activities Assessment Scale (AAS) by 1 week after surgery. The AAS is a 13-point scale on which patients rate their difficulty performing a range of activities from &quot;No difficulty&quot; to &quot;Not able to do it.&quot; A final score ranging from 0-100 is transformed, with higher numbers reflecting less difficulty with activities.&#xD;
We defined return to normal as when a patient's postoperative AAS scores was at or greater than the baseline AAS score. We report the proportion of patients in each study arm who returned to baseline activity at each timepoint.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Return to Baseline Activities Using the Activities Assessment Scale</measure>
    <time_frame>2 week postoperative</time_frame>
    <description>Resumed normal daily activities using the Activities Assessment Scale (AAS) by 2 weeks after surgery. The AAS is a 13-point scale on which patients rate their difficulty performing a range of activities from &quot;No difficulty&quot; to &quot;Not able to do it.&quot; A final score ranging from 0-100 is transformed, with higher numbers reflecting less difficulty with activities.&#xD;
We defined return to normal as when a patient's postoperative AAS scores was at or greater than the baseline AAS score. We report the proportion of patients in each study arm who returned to baseline activity at each timepoint.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Return to Baseline Activities Using the Activities Assessment Scale</measure>
    <time_frame>6 weeks postoperative</time_frame>
    <description>Resumed normal daily activities using the Activities Assessment Scale (AAS) by 6 weeks after surgery. The AAS is a 13-point scale on which patients rate their difficulty performing a range of activities from &quot;No difficulty&quot; to &quot;Not able to do it.&quot; A final score ranging from 0-100 is transformed, with higher numbers reflecting less difficulty with activities.&#xD;
We defined return to normal as when a patient's postoperative AAS scores was at or greater than the baseline AAS score. We report the proportion of patients in each study arm who returned to baseline activity at each timepoint.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Return to Baseline Activities Using the Activities Assessment Scale</measure>
    <time_frame>12 weeks postoperative</time_frame>
    <description>Resumed normal daily activities using the Activities Assessment Scale (AAS) by 12 weeks after surgery. The AAS is a 13-point scale on which patients rate their difficulty performing a range of activities from &quot;No difficulty&quot; to &quot;Not able to do it.&quot; A final score ranging from 0-100 is transformed, with higher numbers reflecting less difficulty with activities.&#xD;
We defined return to normal as when a patient's postoperative AAS scores was at or greater than the baseline AAS score. We report the proportion of patients in each study arm who returned to baseline activity at each timepoint.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>POD 1 Narcotic Consumption</measure>
    <time_frame>Postoperative day 1</time_frame>
    <description>The total amount of narcotic pain medication used on postoperative day 1 was calculated and measured in oral morphine equivalents.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>POD 2 Narcotic Consumption</measure>
    <time_frame>Postoperative day 2</time_frame>
    <description>The total amount of narcotic pain medication used on postoperative day 2 was calculated and measured in oral morphine equivalents.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>POD 3 Narcotic Consumption</measure>
    <time_frame>Postoperative day 3</time_frame>
    <description>The total amount of narcotic pain medication used on postoperative day 3 was calculated and measured in oral morphine equivalents.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>POD 1 Ibuprofen Consumption</measure>
    <time_frame>Postoperative day 1</time_frame>
    <description>The total amount of ibuprofen medication used on postoperative day 1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>POD 2 Ibuprofen Consumption</measure>
    <time_frame>Postoperative day 2</time_frame>
    <description>The total amount of ibuprofen medication used on postoperative day 2.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>POD 3 Ibuprofen Consumption</measure>
    <time_frame>Postoperative day 3</time_frame>
    <description>The total amount of ibuprofen medication used on postoperative day 3.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">79</enrollment>
  <condition>Pelvic Organ Prolapse</condition>
  <condition>Surgery</condition>
  <condition>Postoperative Pain</condition>
  <arm_group>
    <arm_group_label>Bupivacaine/Dexamethasone Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen (transobturator). After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bupivacaine Arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen (transobturator). After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.25% bupivacaine (2.5mg/milliliter). The total amount will be divided equally between the four injection sites.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Arm</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen (transobturator). After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.9% saline (normal saline). The total amount will be divided equally between the four injection sites.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexamethasone</intervention_name>
    <description>Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.</description>
    <arm_group_label>Bupivacaine/Dexamethasone Arm</arm_group_label>
    <other_name>Decadron</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupivacaine</intervention_name>
    <description>Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.</description>
    <arm_group_label>Bupivacaine Arm</arm_group_label>
    <arm_group_label>Bupivacaine/Dexamethasone Arm</arm_group_label>
    <other_name>Marcaine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Bilateral Pudendal Nerve Block</intervention_name>
    <description>Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm medial and inferior to the ischial spine. When the needle guide is properly positioned, the spinal needle is advanced approximately 1cm through the vaginal mucosa into the sacrospinous ligament. The needle will be aspirated to ensure no intravascular needle placement. With a negative aspirate, 5 milliliters of solution are injected. This same procedure will be performed on the contralateral side.</description>
    <arm_group_label>Bupivacaine Arm</arm_group_label>
    <arm_group_label>Bupivacaine/Dexamethasone Arm</arm_group_label>
    <arm_group_label>Placebo Arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Bilateral Levator Ani Muscle Injection</intervention_name>
    <description>Performed transperineally. With thumb, superomedial aspect of obturator foramen is palpated 2-3 cm lateral to the clitoris. The index and middle finger are in the vagina to confirm obturator foramen. A spinal needle is inserted through the the obturator foramen into the obturator internus muscle. The needle is angled slightly posteriorly towards the ischial spine, parallel to the arcus tendineus levator ani and arcus tendineus fascia pelvis. The needle is advanced to the level of the ischial spine, the vaginal hand ensuring that the needle has not perforated the vaginal wall. Once the needle tip is at a depth of the ischial spine, aspiration is performed to ensure no intravascular needle placement. 5 milliliters of solution is injected along the length of the needle tract.</description>
    <arm_group_label>Bupivacaine Arm</arm_group_label>
    <arm_group_label>Bupivacaine/Dexamethasone Arm</arm_group_label>
    <arm_group_label>Placebo Arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Saline</intervention_name>
    <description>Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.</description>
    <arm_group_label>Placebo Arm</arm_group_label>
    <other_name>Normal Saline</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Women ages 18 or older who are scheduled for a vaginal native tissue repair with&#xD;
             apical support procedure including uterosacral ligament suspension, sacrospinous&#xD;
             ligament fixation, or colpectomy and colpocleisis with or without levator myorrhaphy&#xD;
&#xD;
          2. Concomitant procedures including hysterectomy, anterior and posterior colporrhaphies ,&#xD;
             perineorrhaphies and midurethral sling placements are acceptable and do not result in&#xD;
             exclusion&#xD;
&#xD;
          3. Available for at least 12 weeks of follow-up&#xD;
&#xD;
          4. Able to undergoing general anesthesia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Planned mesh-augmented apical support procedure (placement of synthetic midurethral&#xD;
             sling is acceptable and not considered an exclusion criteria)&#xD;
&#xD;
          2. Planned mesh excision&#xD;
&#xD;
          3. Laparoscopic, robotic or abdominal surgery&#xD;
&#xD;
          4. Known adverse reaction or allergy to intervention medication&#xD;
&#xD;
          5. Evidence of fistula or known infection (vulvovaginal cellulitis, abscess,&#xD;
             abdominopelvic infection, or systemic fungal infection)&#xD;
&#xD;
          6. Chronic pelvic pain as an active issue&#xD;
&#xD;
          7. Daily opiate consumption for any indication&#xD;
&#xD;
          8. History of pelvic radiation&#xD;
&#xD;
          9. Chronic steroid use&#xD;
&#xD;
         10. Diabetes mellitus&#xD;
&#xD;
         11. Known HIV/AIDS or immunosuppression secondary to transplant related medications&#xD;
&#xD;
         12. Planned surgery under regional anesthesia&#xD;
&#xD;
         13. Non-English speaking or inability to complete questionnaires&#xD;
&#xD;
         14. Bleeding disorders that would impair a patient's clotting ability&#xD;
&#xD;
         15. Weight less than 50kg&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lauren Giugale, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pittsburgh</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Magee-Womens Hospital of UPMC</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Dexamethasone (systemic): Drug information. UpToDate; 2016. Accessed November 9, 2016.</citation>
  </reference>
  <reference>
    <citation>Bupivacaine: Drug Information. UpToDate; 2016.</citation>
  </reference>
  <reference>
    <citation>Hsu D. Infiltration of local anesthetics. UpToDate. 2016. Accessed November 30, 2016.</citation>
  </reference>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>January 25, 2017</study_first_submitted>
  <study_first_submitted_qc>January 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 1, 2017</study_first_posted>
  <results_first_submitted>February 7, 2020</results_first_submitted>
  <results_first_submitted_qc>March 6, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">March 9, 2020</results_first_posted>
  <last_update_submitted>March 6, 2020</last_update_submitted>
  <last_update_submitted_qc>March 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Pittsburgh</investigator_affiliation>
    <investigator_full_name>Lauren Giugale, MD</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Vaginal Surgery</keyword>
  <keyword>Pelvic Organ Prolapse</keyword>
  <keyword>Postoperative Pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
    <mesh_term>Prolapse</mesh_term>
    <mesh_term>Pelvic Organ Prolapse</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexamethasone</mesh_term>
    <mesh_term>Bupivacaine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 24, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/11/NCT03040011/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 6, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/11/NCT03040011/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>After enrollment but before randomization, 4 patients withdrew from the study: surgical location changed (n=1), declined to participate (n=1), unsafe for general anesthesia (n=1), reported lidocaine allergy (n=1). Because they withdrew prior to randomization, we received permission to enroll an additional 4 patients to meet goal sample size of 75.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Bupivacaine/Dexamethasone Arm</title>
          <description>After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites.&#xD;
Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.&#xD;
Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.&#xD;
Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam</description>
        </group>
        <group group_id="P2">
          <title>Bupivacaine Arm</title>
          <description>After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.25% bupivacaine (2.5mg/milliliter). The total amount will be divided equally between the four injection sites.&#xD;
Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.&#xD;
Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm m</description>
        </group>
        <group group_id="P3">
          <title>Placebo Arm</title>
          <description>After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.9% saline (normal saline). The total amount will be divided equally between the four injection sites.&#xD;
Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm medial and inferior to the ischial spine. When the needle guide is properly positioned, the spinal needle is advanced approx</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Received Randomized Study Intervention</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="25"/>
                <participants group_id="P3" count="25"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="25"/>
                <participants group_id="P3" count="25"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Primary Outcome Follow Up</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="25"/>
                <participants group_id="P3" count="25"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="21">Postoperative day one pain score not available for four patients</participants>
                <participants group_id="P2" count="24">Postoperative day one pain score not available for one patient</participants>
                <participants group_id="P3" count="24">Postoperative day one pain score not available for one patient</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Bupivacaine/Dexamethasone Arm</title>
          <description>After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites.&#xD;
Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.&#xD;
Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.&#xD;
Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam</description>
        </group>
        <group group_id="B2">
          <title>Bupivacaine Arm</title>
          <description>After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.25% bupivacaine (2.5mg/milliliter). The total amount will be divided equally between the four injection sites.&#xD;
Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.&#xD;
Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm m</description>
        </group>
        <group group_id="B3">
          <title>Placebo Arm</title>
          <description>After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.9% saline (normal saline). The total amount will be divided equally between the four injection sites.&#xD;
Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm medial and inferior to the ischial spine. When the needle guide is properly positioned, the spinal needle is advanced approx</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="25"/>
            <count group_id="B2" value="25"/>
            <count group_id="B3" value="25"/>
            <count group_id="B4" value="75"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="25"/>
                    <count group_id="B2" value="25"/>
                    <count group_id="B3" value="25"/>
                    <count group_id="B4" value="75"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="68.8" spread="13.6"/>
                    <measurement group_id="B2" value="68.0" spread="10.1"/>
                    <measurement group_id="B3" value="70.2" spread="9.2"/>
                    <measurement group_id="B4" value="69.0" spread="11.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="25"/>
                    <count group_id="B2" value="25"/>
                    <count group_id="B3" value="25"/>
                    <count group_id="B4" value="75"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="25"/>
                    <measurement group_id="B4" value="75"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="25"/>
                    <count group_id="B2" value="25"/>
                    <count group_id="B3" value="25"/>
                    <count group_id="B4" value="75"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="24"/>
                    <measurement group_id="B4" value="67"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                    <count group_id="B4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="25"/>
                    <count group_id="B2" value="25"/>
                    <count group_id="B3" value="25"/>
                    <count group_id="B4" value="75"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="25"/>
                    <measurement group_id="B4" value="75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline NRS Pain Score</title>
          <description>Pain measured by the numerical rating scale (NRS) prior to surgery. The Numeric Rating Scale is an 11 point scale ranging from 0-10 with higher scores indicating worse pain.</description>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="25"/>
                    <count group_id="B2" value="25"/>
                    <count group_id="B3" value="25"/>
                    <count group_id="B4" value="75"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="B2" value="0" lower_limit="0" upper_limit="0.3"/>
                    <measurement group_id="B3" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="B4" value="0" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline NV Score</title>
          <description>Any preoperative nausea and vomiting was assessed by administering the Postoperative Nausea and Vomiting Intensity Scale prior to surgery. The Postoperative Nausea and Vomiting Intensity Scale is a four-question assessment to measure clinically significant nausea and vomiting with a range from 0-7 with higher scores signifying more clinically significant nausea and vomiting. We chose to utilize this scale before and after surgery for consistency.</description>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="25"/>
                    <count group_id="B2" value="25"/>
                    <count group_id="B3" value="25"/>
                    <count group_id="B4" value="75"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="B2" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="B3" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="B4" value="0" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline AAS Score</title>
          <description>The AAS is a 13-point scale on which patients rate their difficulty performing a range of activities from &quot;No difficulty&quot; to &quot;Not able to do it.&quot; A final score ranging from 0-100 is transformed, with higher numbers reflecting less difficulty with activities.</description>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="25"/>
                    <count group_id="B2" value="25"/>
                    <count group_id="B3" value="25"/>
                    <count group_id="B4" value="75"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="94.6" lower_limit="85.2" upper_limit="100"/>
                    <measurement group_id="B2" value="92.3" lower_limit="70.6" upper_limit="100"/>
                    <measurement group_id="B3" value="95.5" lower_limit="81.3" upper_limit="100"/>
                    <measurement group_id="B4" value="94.2" lower_limit="79.4" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Prolapse Procedure</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Uterosacral Ligament Suspension</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="25"/>
                    <count group_id="B2" value="25"/>
                    <count group_id="B3" value="25"/>
                    <count group_id="B4" value="75"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="11"/>
                    <measurement group_id="B4" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sacrospinous Ligament Fixation</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="25"/>
                    <count group_id="B2" value="25"/>
                    <count group_id="B3" value="25"/>
                    <count group_id="B4" value="75"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Colpocleisis</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="25"/>
                    <count group_id="B2" value="25"/>
                    <count group_id="B3" value="25"/>
                    <count group_id="B4" value="75"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Levator Myorrhaphy</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="25"/>
                    <count group_id="B2" value="25"/>
                    <count group_id="B3" value="25"/>
                    <count group_id="B4" value="75"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Primary Postoperative Pain Measured by the Numerical Rating Scale (NRS)</title>
        <description>Postoperative pain measured by the numerical rating scale (NRS) at 24 hours postoperatively. The Numeric Rating Scale is an 11 point scale ranging from 0-10 with higher scores indicating worse pain.</description>
        <time_frame>24 hours postoperatively</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Bupivacaine/Dexamethasone Arm</title>
            <description>After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites.&#xD;
Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.&#xD;
Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.&#xD;
Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam</description>
          </group>
          <group group_id="O2">
            <title>Bupivacaine Arm</title>
            <description>After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.25% bupivacaine (2.5mg/milliliter). The total amount will be divided equally between the four injection sites.&#xD;
Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.&#xD;
Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm m</description>
          </group>
          <group group_id="O3">
            <title>Placebo Arm</title>
            <description>After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.9% saline (normal saline). The total amount will be divided equally between the four injection sites.&#xD;
Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm medial and inferior to the ischial spine. When the needle guide is properly positioned, the spinal needle is advanced approx</description>
          </group>
        </group_list>
        <measure>
          <title>Primary Postoperative Pain Measured by the Numerical Rating Scale (NRS)</title>
          <description>Postoperative pain measured by the numerical rating scale (NRS) at 24 hours postoperatively. The Numeric Rating Scale is an 11 point scale ranging from 0-10 with higher scores indicating worse pain.</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="24"/>
                <count group_id="O3" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.0" lower_limit="1.0" upper_limit="5.0"/>
                    <measurement group_id="O2" value="4.0" lower_limit="2.0" upper_limit="5.0"/>
                    <measurement group_id="O3" value="3.75" lower_limit="2.0" upper_limit="6.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.39</p_value>
            <method>Kruskal-Wallis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>6 Hour Postoperative Pain Measured by the NRS</title>
        <description>Postoperative pain as measured by the NRS at 6 hours after surgery. The Numeric Rating Scale is an 11 point scale ranging from 0-10 with higher scores indicating worse pain.&#xD;
Of note, there is a typographical error in the protocol section and refers to this outcome as a NRS score at 3 hours postoperatively. The final IRB approved protocol is a 6 hour postoperative timepoint and this is the correct outcome reported here in the results section.</description>
        <time_frame>6 hours postoperatively</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Bupivacaine/Dexamethasone Arm</title>
            <description>After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites.&#xD;
Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.&#xD;
Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.&#xD;
Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam</description>
          </group>
          <group group_id="O2">
            <title>Bupivacaine Arm</title>
            <description>After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.25% bupivacaine (2.5mg/milliliter). The total amount will be divided equally between the four injection sites.&#xD;
Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.&#xD;
Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm m</description>
          </group>
          <group group_id="O3">
            <title>Placebo Arm</title>
            <description>After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.9% saline (normal saline). The total amount will be divided equally between the four injection sites.&#xD;
Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm medial and inferior to the ischial spine. When the needle guide is properly positioned, the spinal needle is advanced approx</description>
          </group>
        </group_list>
        <measure>
          <title>6 Hour Postoperative Pain Measured by the NRS</title>
          <description>Postoperative pain as measured by the NRS at 6 hours after surgery. The Numeric Rating Scale is an 11 point scale ranging from 0-10 with higher scores indicating worse pain.&#xD;
Of note, there is a typographical error in the protocol section and refers to this outcome as a NRS score at 3 hours postoperatively. The final IRB approved protocol is a 6 hour postoperative timepoint and this is the correct outcome reported here in the results section.</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="25"/>
                <count group_id="O3" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" lower_limit="0.5" upper_limit="4.0"/>
                    <measurement group_id="O2" value="3.0" lower_limit="2.0" upper_limit="4.0"/>
                    <measurement group_id="O3" value="1.75" lower_limit="0.6" upper_limit="4.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.25</p_value>
            <method>Kruskal-Wallis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>POD 2 Postoperative Pain Measured by the NRS</title>
        <description>Postoperative Pain Measured by the NRS 2 days after surgery. The Numeric Rating Scale is an 11 point scale ranging from 0-10 with higher scores indicating worse pain.</description>
        <time_frame>2 days after surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Bupivacaine/Dexamethasone Arm</title>
            <description>After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites.&#xD;
Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.&#xD;
Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.&#xD;
Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam</description>
          </group>
          <group group_id="O2">
            <title>Bupivacaine Arm</title>
            <description>After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.25% bupivacaine (2.5mg/milliliter). The total amount will be divided equally between the four injection sites.&#xD;
Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.&#xD;
Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm m</description>
          </group>
          <group group_id="O3">
            <title>Placebo Arm</title>
            <description>After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.9% saline (normal saline). The total amount will be divided equally between the four injection sites.&#xD;
Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm medial and inferior to the ischial spine. When the needle guide is properly positioned, the spinal needle is advanced approx</description>
          </group>
        </group_list>
        <measure>
          <title>POD 2 Postoperative Pain Measured by the NRS</title>
          <description>Postoperative Pain Measured by the NRS 2 days after surgery. The Numeric Rating Scale is an 11 point scale ranging from 0-10 with higher scores indicating worse pain.</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="25"/>
                <count group_id="O3" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.0" lower_limit="1.0" upper_limit="5.0"/>
                    <measurement group_id="O2" value="3.0" lower_limit="2.0" upper_limit="4.0"/>
                    <measurement group_id="O3" value="4.0" lower_limit="2.8" upper_limit="6.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.17</p_value>
            <method>Kruskal-Wallis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>POD 3 Postoperative Pain Measured by the NRS</title>
        <description>Postoperative Pain Measured by the NRS 3 days after surgery. The Numeric Rating Scale is an 11 point scale ranging from 0-10 with higher scores indicating worse pain.</description>
        <time_frame>3 days after surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Bupivacaine/Dexamethasone Arm</title>
            <description>After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites.&#xD;
Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.&#xD;
Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.&#xD;
Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam</description>
          </group>
          <group group_id="O2">
            <title>Bupivacaine Arm</title>
            <description>After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.25% bupivacaine (2.5mg/milliliter). The total amount will be divided equally between the four injection sites.&#xD;
Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.&#xD;
Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm m</description>
          </group>
          <group group_id="O3">
            <title>Placebo Arm</title>
            <description>After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.9% saline (normal saline). The total amount will be divided equally between the four injection sites.&#xD;
Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm medial and inferior to the ischial spine. When the needle guide is properly positioned, the spinal needle is advanced approx</description>
          </group>
        </group_list>
        <measure>
          <title>POD 3 Postoperative Pain Measured by the NRS</title>
          <description>Postoperative Pain Measured by the NRS 3 days after surgery. The Numeric Rating Scale is an 11 point scale ranging from 0-10 with higher scores indicating worse pain.</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="25"/>
                <count group_id="O3" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.0" lower_limit="2.0" upper_limit="5.0"/>
                    <measurement group_id="O2" value="2.5" lower_limit="2.0" upper_limit="3.3"/>
                    <measurement group_id="O3" value="3.5" lower_limit="0.5" upper_limit="5.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.45</p_value>
            <method>Kruskal-Wallis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>1 Week Postoperative Pain Measured by the NRS</title>
        <description>Postoperative Pain Measured by the Numeric Rating Scale 1 week after surgery. The Numeric Rating Scale is an 11 point scale ranging from 0-10 with higher scores indicating worse pain.</description>
        <time_frame>1 week after surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Bupivacaine/Dexamethasone Arm</title>
            <description>After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites.&#xD;
Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.&#xD;
Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.&#xD;
Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam</description>
          </group>
          <group group_id="O2">
            <title>Bupivacaine Arm</title>
            <description>After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.25% bupivacaine (2.5mg/milliliter). The total amount will be divided equally between the four injection sites.&#xD;
Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.&#xD;
Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm m</description>
          </group>
          <group group_id="O3">
            <title>Placebo Arm</title>
            <description>After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.9% saline (normal saline). The total amount will be divided equally between the four injection sites.&#xD;
Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm medial and inferior to the ischial spine. When the needle guide is properly positioned, the spinal needle is advanced approx</description>
          </group>
        </group_list>
        <measure>
          <title>1 Week Postoperative Pain Measured by the NRS</title>
          <description>Postoperative Pain Measured by the Numeric Rating Scale 1 week after surgery. The Numeric Rating Scale is an 11 point scale ranging from 0-10 with higher scores indicating worse pain.</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="25"/>
                <count group_id="O3" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.75" lower_limit="1.0" upper_limit="2.75"/>
                    <measurement group_id="O2" value="2.0" lower_limit="1.0" upper_limit="4.0"/>
                    <measurement group_id="O3" value="1.0" lower_limit="0.0" upper_limit="3.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.54</p_value>
            <method>Kruskal-Wallis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Patients With Same Day Discharge</title>
        <description>Same day discharge was defined as a patient being discharged on the same day as surgery and did not require an admission after surgery. The proportion of patients who were discharged on the day of surgery was compared between groups.</description>
        <time_frame>Day of surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Bupivacaine/Dexamethasone Arm</title>
            <description>After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites.&#xD;
Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.&#xD;
Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.&#xD;
Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam</description>
          </group>
          <group group_id="O2">
            <title>Bupivacaine Arm</title>
            <description>After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.25% bupivacaine (2.5mg/milliliter). The total amount will be divided equally between the four injection sites.&#xD;
Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.&#xD;
Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm m</description>
          </group>
          <group group_id="O3">
            <title>Placebo Arm</title>
            <description>After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.9% saline (normal saline). The total amount will be divided equally between the four injection sites.&#xD;
Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm medial and inferior to the ischial spine. When the needle guide is properly positioned, the spinal needle is advanced approx</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Patients With Same Day Discharge</title>
          <description>Same day discharge was defined as a patient being discharged on the same day as surgery and did not require an admission after surgery. The proportion of patients who were discharged on the day of surgery was compared between groups.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="25"/>
                <count group_id="O3" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="22"/>
                    <measurement group_id="O3" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.80</p_value>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Postoperative Urinary Retention</title>
        <description>Urinary retention was defined as the need to perform self-catheterization or have an indwelling catheter placed postoperatively. The proportion of patients with urinary retention was compared between groups.</description>
        <time_frame>0-24 hours postoperatively</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Bupivacaine/Dexamethasone Arm</title>
            <description>After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites.&#xD;
Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.&#xD;
Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.&#xD;
Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam</description>
          </group>
          <group group_id="O2">
            <title>Bupivacaine Arm</title>
            <description>After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.25% bupivacaine (2.5mg/milliliter). The total amount will be divided equally between the four injection sites.&#xD;
Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.&#xD;
Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm m</description>
          </group>
          <group group_id="O3">
            <title>Placebo Arm</title>
            <description>After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.9% saline (normal saline). The total amount will be divided equally between the four injection sites.&#xD;
Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm medial and inferior to the ischial spine. When the needle guide is properly positioned, the spinal needle is advanced approx</description>
          </group>
        </group_list>
        <measure>
          <title>Postoperative Urinary Retention</title>
          <description>Urinary retention was defined as the need to perform self-catheterization or have an indwelling catheter placed postoperatively. The proportion of patients with urinary retention was compared between groups.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="25"/>
                <count group_id="O3" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="11"/>
                    <measurement group_id="O3" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.72</p_value>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Adverse Events</title>
        <description>The number of adverse events in each study group was assessed and compared between study groups. An adverse event was described as any medical or surgical complication that occurred either intraoperatively or postoperatively.</description>
        <time_frame>0-12 weeks postoperatively</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Bupivacaine/Dexamethasone Arm</title>
            <description>After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites.&#xD;
Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.&#xD;
Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.&#xD;
Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam</description>
          </group>
          <group group_id="O2">
            <title>Bupivacaine Arm</title>
            <description>After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.25% bupivacaine (2.5mg/milliliter). The total amount will be divided equally between the four injection sites.&#xD;
Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.&#xD;
Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm m</description>
          </group>
          <group group_id="O3">
            <title>Placebo Arm</title>
            <description>After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.9% saline (normal saline). The total amount will be divided equally between the four injection sites.&#xD;
Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm medial and inferior to the ischial spine. When the needle guide is properly positioned, the spinal needle is advanced approx</description>
          </group>
        </group_list>
        <measure>
          <title>Adverse Events</title>
          <description>The number of adverse events in each study group was assessed and compared between study groups. An adverse event was described as any medical or surgical complication that occurred either intraoperatively or postoperatively.</description>
          <units>number of adverse events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="25"/>
                <count group_id="O3" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.64</p_value>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Nausea and Vomiting Measured by the PONV Scale</title>
        <description>Intensity of postoperative nausea and vomiting (PONV) measured by the PONV scale prior to discharge. The Postoperative Nausea and Vomiting Intensity Scale is a four-question assessment to measure clinically significant nausea and vomiting with a range from 0-7 with higher scores signifying more clinically significant nausea and vomiting.</description>
        <time_frame>6 hours postoperatively</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Bupivacaine/Dexamethasone Arm</title>
            <description>After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites.&#xD;
Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.&#xD;
Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.&#xD;
Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam</description>
          </group>
          <group group_id="O2">
            <title>Bupivacaine Arm</title>
            <description>After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.25% bupivacaine (2.5mg/milliliter). The total amount will be divided equally between the four injection sites.&#xD;
Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.&#xD;
Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm m</description>
          </group>
          <group group_id="O3">
            <title>Placebo Arm</title>
            <description>After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.9% saline (normal saline). The total amount will be divided equally between the four injection sites.&#xD;
Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm medial and inferior to the ischial spine. When the needle guide is properly positioned, the spinal needle is advanced approx</description>
          </group>
        </group_list>
        <measure>
          <title>Nausea and Vomiting Measured by the PONV Scale</title>
          <description>Intensity of postoperative nausea and vomiting (PONV) measured by the PONV scale prior to discharge. The Postoperative Nausea and Vomiting Intensity Scale is a four-question assessment to measure clinically significant nausea and vomiting with a range from 0-7 with higher scores signifying more clinically significant nausea and vomiting.</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="25"/>
                <count group_id="O3" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O3" value="0" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.41</p_value>
            <method>Kruskal-Wallis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Anti-emetic Consumption</title>
        <description>The amount of inpatient anti-emetic consumption, recorded in number of doses of nausea medication</description>
        <time_frame>3 hours postoperatively</time_frame>
        <population>This data was not collected. Rather, we assessed the PONV score which is described in outcome number 9.</population>
        <group_list>
          <group group_id="O1">
            <title>Bupivacaine/Dexamethasone Arm</title>
            <description>After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites.&#xD;
Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.&#xD;
Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.&#xD;
Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam</description>
          </group>
          <group group_id="O2">
            <title>Bupivacaine Arm</title>
            <description>After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.25% bupivacaine (2.5mg/milliliter). The total amount will be divided equally between the four injection sites.&#xD;
Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.&#xD;
Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm m</description>
          </group>
          <group group_id="O3">
            <title>Placebo Arm</title>
            <description>After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.9% saline (normal saline). The total amount will be divided equally between the four injection sites.&#xD;
Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm medial and inferior to the ischial spine. When the needle guide is properly positioned, the spinal needle is advanced approx</description>
          </group>
        </group_list>
        <measure>
          <title>Anti-emetic Consumption</title>
          <description>The amount of inpatient anti-emetic consumption, recorded in number of doses of nausea medication</description>
          <population>This data was not collected. Rather, we assessed the PONV score which is described in outcome number 9.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Return to Baseline Activities Using the Activities Assessment Scale</title>
        <description>Resumed normal daily activities using the Activities Assessment Scale (AAS) by 1 week after surgery. The AAS is a 13-point scale on which patients rate their difficulty performing a range of activities from &quot;No difficulty&quot; to &quot;Not able to do it.&quot; A final score ranging from 0-100 is transformed, with higher numbers reflecting less difficulty with activities.&#xD;
We defined return to normal as when a patient's postoperative AAS scores was at or greater than the baseline AAS score. We report the proportion of patients in each study arm who returned to baseline activity at each timepoint.</description>
        <time_frame>1 week postoperative</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Bupivacaine/Dexamethasone Arm</title>
            <description>After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites.&#xD;
Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.&#xD;
Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.&#xD;
Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam</description>
          </group>
          <group group_id="O2">
            <title>Bupivacaine Arm</title>
            <description>After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.25% bupivacaine (2.5mg/milliliter). The total amount will be divided equally between the four injection sites.&#xD;
Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.&#xD;
Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm m</description>
          </group>
          <group group_id="O3">
            <title>Placebo Arm</title>
            <description>After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.9% saline (normal saline). The total amount will be divided equally between the four injection sites.&#xD;
Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm medial and inferior to the ischial spine. When the needle guide is properly positioned, the spinal needle is advanced approx</description>
          </group>
        </group_list>
        <measure>
          <title>Return to Baseline Activities Using the Activities Assessment Scale</title>
          <description>Resumed normal daily activities using the Activities Assessment Scale (AAS) by 1 week after surgery. The AAS is a 13-point scale on which patients rate their difficulty performing a range of activities from &quot;No difficulty&quot; to &quot;Not able to do it.&quot; A final score ranging from 0-100 is transformed, with higher numbers reflecting less difficulty with activities.&#xD;
We defined return to normal as when a patient's postoperative AAS scores was at or greater than the baseline AAS score. We report the proportion of patients in each study arm who returned to baseline activity at each timepoint.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="25"/>
                <count group_id="O3" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="11"/>
                    <measurement group_id="O3" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.96</p_value>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Return to Baseline Activities Using the Activities Assessment Scale</title>
        <description>Resumed normal daily activities using the Activities Assessment Scale (AAS) by 2 weeks after surgery. The AAS is a 13-point scale on which patients rate their difficulty performing a range of activities from &quot;No difficulty&quot; to &quot;Not able to do it.&quot; A final score ranging from 0-100 is transformed, with higher numbers reflecting less difficulty with activities.&#xD;
We defined return to normal as when a patient's postoperative AAS scores was at or greater than the baseline AAS score. We report the proportion of patients in each study arm who returned to baseline activity at each timepoint.</description>
        <time_frame>2 week postoperative</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Bupivacaine/Dexamethasone Arm</title>
            <description>After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites.&#xD;
Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.&#xD;
Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.&#xD;
Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam</description>
          </group>
          <group group_id="O2">
            <title>Bupivacaine Arm</title>
            <description>After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.25% bupivacaine (2.5mg/milliliter). The total amount will be divided equally between the four injection sites.&#xD;
Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.&#xD;
Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm m</description>
          </group>
          <group group_id="O3">
            <title>Placebo Arm</title>
            <description>After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.9% saline (normal saline). The total amount will be divided equally between the four injection sites.&#xD;
Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm medial and inferior to the ischial spine. When the needle guide is properly positioned, the spinal needle is advanced approx</description>
          </group>
        </group_list>
        <measure>
          <title>Return to Baseline Activities Using the Activities Assessment Scale</title>
          <description>Resumed normal daily activities using the Activities Assessment Scale (AAS) by 2 weeks after surgery. The AAS is a 13-point scale on which patients rate their difficulty performing a range of activities from &quot;No difficulty&quot; to &quot;Not able to do it.&quot; A final score ranging from 0-100 is transformed, with higher numbers reflecting less difficulty with activities.&#xD;
We defined return to normal as when a patient's postoperative AAS scores was at or greater than the baseline AAS score. We report the proportion of patients in each study arm who returned to baseline activity at each timepoint.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="25"/>
                <count group_id="O3" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="16"/>
                    <measurement group_id="O3" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.90</p_value>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Return to Baseline Activities Using the Activities Assessment Scale</title>
        <description>Resumed normal daily activities using the Activities Assessment Scale (AAS) by 6 weeks after surgery. The AAS is a 13-point scale on which patients rate their difficulty performing a range of activities from &quot;No difficulty&quot; to &quot;Not able to do it.&quot; A final score ranging from 0-100 is transformed, with higher numbers reflecting less difficulty with activities.&#xD;
We defined return to normal as when a patient's postoperative AAS scores was at or greater than the baseline AAS score. We report the proportion of patients in each study arm who returned to baseline activity at each timepoint.</description>
        <time_frame>6 weeks postoperative</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Bupivacaine/Dexamethasone Arm</title>
            <description>After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites.&#xD;
Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.&#xD;
Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.&#xD;
Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam</description>
          </group>
          <group group_id="O2">
            <title>Bupivacaine Arm</title>
            <description>After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.25% bupivacaine (2.5mg/milliliter). The total amount will be divided equally between the four injection sites.&#xD;
Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.&#xD;
Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm m</description>
          </group>
          <group group_id="O3">
            <title>Placebo Arm</title>
            <description>After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.9% saline (normal saline). The total amount will be divided equally between the four injection sites.&#xD;
Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm medial and inferior to the ischial spine. When the needle guide is properly positioned, the spinal needle is advanced approx</description>
          </group>
        </group_list>
        <measure>
          <title>Return to Baseline Activities Using the Activities Assessment Scale</title>
          <description>Resumed normal daily activities using the Activities Assessment Scale (AAS) by 6 weeks after surgery. The AAS is a 13-point scale on which patients rate their difficulty performing a range of activities from &quot;No difficulty&quot; to &quot;Not able to do it.&quot; A final score ranging from 0-100 is transformed, with higher numbers reflecting less difficulty with activities.&#xD;
We defined return to normal as when a patient's postoperative AAS scores was at or greater than the baseline AAS score. We report the proportion of patients in each study arm who returned to baseline activity at each timepoint.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="25"/>
                <count group_id="O3" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="17"/>
                    <measurement group_id="O3" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.49</p_value>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Return to Baseline Activities Using the Activities Assessment Scale</title>
        <description>Resumed normal daily activities using the Activities Assessment Scale (AAS) by 12 weeks after surgery. The AAS is a 13-point scale on which patients rate their difficulty performing a range of activities from &quot;No difficulty&quot; to &quot;Not able to do it.&quot; A final score ranging from 0-100 is transformed, with higher numbers reflecting less difficulty with activities.&#xD;
We defined return to normal as when a patient's postoperative AAS scores was at or greater than the baseline AAS score. We report the proportion of patients in each study arm who returned to baseline activity at each timepoint.</description>
        <time_frame>12 weeks postoperative</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Bupivacaine/Dexamethasone Arm</title>
            <description>After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites.&#xD;
Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.&#xD;
Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.&#xD;
Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam</description>
          </group>
          <group group_id="O2">
            <title>Bupivacaine Arm</title>
            <description>After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.25% bupivacaine (2.5mg/milliliter). The total amount will be divided equally between the four injection sites.&#xD;
Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.&#xD;
Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm m</description>
          </group>
          <group group_id="O3">
            <title>Placebo Arm</title>
            <description>After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.9% saline (normal saline). The total amount will be divided equally between the four injection sites.&#xD;
Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm medial and inferior to the ischial spine. When the needle guide is properly positioned, the spinal needle is advanced approx</description>
          </group>
        </group_list>
        <measure>
          <title>Return to Baseline Activities Using the Activities Assessment Scale</title>
          <description>Resumed normal daily activities using the Activities Assessment Scale (AAS) by 12 weeks after surgery. The AAS is a 13-point scale on which patients rate their difficulty performing a range of activities from &quot;No difficulty&quot; to &quot;Not able to do it.&quot; A final score ranging from 0-100 is transformed, with higher numbers reflecting less difficulty with activities.&#xD;
We defined return to normal as when a patient's postoperative AAS scores was at or greater than the baseline AAS score. We report the proportion of patients in each study arm who returned to baseline activity at each timepoint.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="25"/>
                <count group_id="O3" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="19"/>
                    <measurement group_id="O3" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.19</p_value>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>POD 1 Narcotic Consumption</title>
        <description>The total amount of narcotic pain medication used on postoperative day 1 was calculated and measured in oral morphine equivalents.</description>
        <time_frame>Postoperative day 1</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Bupivacaine/Dexamethasone Arm</title>
            <description>After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites.&#xD;
Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.&#xD;
Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.&#xD;
Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam</description>
          </group>
          <group group_id="O2">
            <title>Bupivacaine Arm</title>
            <description>After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.25% bupivacaine (2.5mg/milliliter). The total amount will be divided equally between the four injection sites.&#xD;
Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.&#xD;
Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm m</description>
          </group>
          <group group_id="O3">
            <title>Placebo Arm</title>
            <description>After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.9% saline (normal saline). The total amount will be divided equally between the four injection sites.&#xD;
Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm medial and inferior to the ischial spine. When the needle guide is properly positioned, the spinal needle is advanced approx</description>
          </group>
        </group_list>
        <measure>
          <title>POD 1 Narcotic Consumption</title>
          <description>The total amount of narcotic pain medication used on postoperative day 1 was calculated and measured in oral morphine equivalents.</description>
          <units>oral morphine equivalents</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="25"/>
                <count group_id="O3" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.5" lower_limit="0.0" upper_limit="15.0"/>
                    <measurement group_id="O2" value="4.4" lower_limit="0.0" upper_limit="10.0"/>
                    <measurement group_id="O3" value="7.5" lower_limit="0.0" upper_limit="22.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.35</p_value>
            <method>Kruskal-Wallis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>POD 2 Narcotic Consumption</title>
        <description>The total amount of narcotic pain medication used on postoperative day 2 was calculated and measured in oral morphine equivalents.</description>
        <time_frame>Postoperative day 2</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Bupivacaine/Dexamethasone Arm</title>
            <description>After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites.&#xD;
Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.&#xD;
Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.&#xD;
Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam</description>
          </group>
          <group group_id="O2">
            <title>Bupivacaine Arm</title>
            <description>After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.25% bupivacaine (2.5mg/milliliter). The total amount will be divided equally between the four injection sites.&#xD;
Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.&#xD;
Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm m</description>
          </group>
          <group group_id="O3">
            <title>Placebo Arm</title>
            <description>After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.9% saline (normal saline). The total amount will be divided equally between the four injection sites.&#xD;
Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm medial and inferior to the ischial spine. When the needle guide is properly positioned, the spinal needle is advanced approx</description>
          </group>
        </group_list>
        <measure>
          <title>POD 2 Narcotic Consumption</title>
          <description>The total amount of narcotic pain medication used on postoperative day 2 was calculated and measured in oral morphine equivalents.</description>
          <units>oral morphine equivalents</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="25"/>
                <count group_id="O3" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.5" lower_limit="0.0" upper_limit="15.0"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="11.9"/>
                    <measurement group_id="O3" value="7.5" lower_limit="0.0" upper_limit="20.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.32</p_value>
            <method>Kruskal-Wallis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>POD 3 Narcotic Consumption</title>
        <description>The total amount of narcotic pain medication used on postoperative day 3 was calculated and measured in oral morphine equivalents.</description>
        <time_frame>Postoperative day 3</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Bupivacaine/Dexamethasone Arm</title>
            <description>After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites.&#xD;
Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.&#xD;
Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.&#xD;
Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam</description>
          </group>
          <group group_id="O2">
            <title>Bupivacaine Arm</title>
            <description>After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.25% bupivacaine (2.5mg/milliliter). The total amount will be divided equally between the four injection sites.&#xD;
Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.&#xD;
Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm m</description>
          </group>
          <group group_id="O3">
            <title>Placebo Arm</title>
            <description>After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.9% saline (normal saline). The total amount will be divided equally between the four injection sites.&#xD;
Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm medial and inferior to the ischial spine. When the needle guide is properly positioned, the spinal needle is advanced approx</description>
          </group>
        </group_list>
        <measure>
          <title>POD 3 Narcotic Consumption</title>
          <description>The total amount of narcotic pain medication used on postoperative day 3 was calculated and measured in oral morphine equivalents.</description>
          <units>oral morphine equivalents</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="25"/>
                <count group_id="O3" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.5" lower_limit="0.0" upper_limit="15.0"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="4.7"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="18.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.18</p_value>
            <method>Kruskal-Wallis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>POD 1 Ibuprofen Consumption</title>
        <description>The total amount of ibuprofen medication used on postoperative day 1.</description>
        <time_frame>Postoperative day 1</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Bupivacaine/Dexamethasone Arm</title>
            <description>After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites.&#xD;
Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.&#xD;
Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.&#xD;
Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam</description>
          </group>
          <group group_id="O2">
            <title>Bupivacaine Arm</title>
            <description>After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.25% bupivacaine (2.5mg/milliliter). The total amount will be divided equally between the four injection sites.&#xD;
Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.&#xD;
Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm m</description>
          </group>
          <group group_id="O3">
            <title>Placebo Arm</title>
            <description>After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.9% saline (normal saline). The total amount will be divided equally between the four injection sites.&#xD;
Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm medial and inferior to the ischial spine. When the needle guide is properly positioned, the spinal needle is advanced approx</description>
          </group>
        </group_list>
        <measure>
          <title>POD 1 Ibuprofen Consumption</title>
          <description>The total amount of ibuprofen medication used on postoperative day 1.</description>
          <units>milligrams</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="25"/>
                <count group_id="O3" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1200" lower_limit="0" upper_limit="2400"/>
                    <measurement group_id="O2" value="1200" lower_limit="750" upper_limit="1800"/>
                    <measurement group_id="O3" value="1200" lower_limit="0" upper_limit="1800"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.68</p_value>
            <method>Kruskal-Wallis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>POD 2 Ibuprofen Consumption</title>
        <description>The total amount of ibuprofen medication used on postoperative day 2.</description>
        <time_frame>Postoperative day 2</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Bupivacaine/Dexamethasone Arm</title>
            <description>After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites.&#xD;
Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.&#xD;
Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.&#xD;
Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam</description>
          </group>
          <group group_id="O2">
            <title>Bupivacaine Arm</title>
            <description>After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.25% bupivacaine (2.5mg/milliliter). The total amount will be divided equally between the four injection sites.&#xD;
Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.&#xD;
Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm m</description>
          </group>
          <group group_id="O3">
            <title>Placebo Arm</title>
            <description>After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.9% saline (normal saline). The total amount will be divided equally between the four injection sites.&#xD;
Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm medial and inferior to the ischial spine. When the needle guide is properly positioned, the spinal needle is advanced approx</description>
          </group>
        </group_list>
        <measure>
          <title>POD 2 Ibuprofen Consumption</title>
          <description>The total amount of ibuprofen medication used on postoperative day 2.</description>
          <units>milligrams</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="25"/>
                <count group_id="O3" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1200" lower_limit="0" upper_limit="2400"/>
                    <measurement group_id="O2" value="1200" lower_limit="750" upper_limit="1800"/>
                    <measurement group_id="O3" value="1800" lower_limit="300" upper_limit="2400"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.40</p_value>
            <method>Kruskal-Wallis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>POD 3 Ibuprofen Consumption</title>
        <description>The total amount of ibuprofen medication used on postoperative day 3.</description>
        <time_frame>Postoperative day 3</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Bupivacaine/Dexamethasone Arm</title>
            <description>After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites.&#xD;
Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.&#xD;
Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.&#xD;
Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam</description>
          </group>
          <group group_id="O2">
            <title>Bupivacaine Arm</title>
            <description>After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.25% bupivacaine (2.5mg/milliliter). The total amount will be divided equally between the four injection sites.&#xD;
Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.&#xD;
Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm m</description>
          </group>
          <group group_id="O3">
            <title>Placebo Arm</title>
            <description>After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.9% saline (normal saline). The total amount will be divided equally between the four injection sites.&#xD;
Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm medial and inferior to the ischial spine. When the needle guide is properly positioned, the spinal needle is advanced approx</description>
          </group>
        </group_list>
        <measure>
          <title>POD 3 Ibuprofen Consumption</title>
          <description>The total amount of ibuprofen medication used on postoperative day 3.</description>
          <units>milligrams</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="25"/>
                <count group_id="O3" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1200" lower_limit="0" upper_limit="2400"/>
                    <measurement group_id="O2" value="1200" lower_limit="0" upper_limit="2250"/>
                    <measurement group_id="O3" value="1800" lower_limit="150" upper_limit="2400"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.44</p_value>
            <method>Kruskal-Wallis</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>12 weeks from the date of surgery</time_frame>
      <desc>Members of the study team including the PI, research staff and coordinator met monthly. Any adverse event that was significant, unexpected and possibly related to the study procedure or medication was reported to the PI, faculty mentor and the IRB within 24 hours. The PI submitted in writing to the IRB a detailed summary of the adverse events for review. After IRB review of the adverse events, a final conclusion and recommendation were provided.</desc>
      <group_list>
        <group group_id="E1">
          <title>Bupivacaine/Dexamethasone Arm</title>
          <description>After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites.&#xD;
Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.&#xD;
Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.&#xD;
Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam</description>
        </group>
        <group group_id="E2">
          <title>Bupivacaine Arm</title>
          <description>After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.25% bupivacaine (2.5mg/milliliter). The total amount will be divided equally between the four injection sites.&#xD;
Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.&#xD;
Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm m</description>
        </group>
        <group group_id="E3">
          <title>Placebo Arm</title>
          <description>After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.9% saline (normal saline). The total amount will be divided equally between the four injection sites.&#xD;
Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm medial and inferior to the ischial spine. When the needle guide is properly positioned, the spinal needle is advanced approx</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Surgical complications</sub_title>
                <description>Surgical complications not thought to be related to study intervention: ureteral obstruction requiring return to the operating room (n=1) and a case with a rectal injury and sponge miscount, which was resolved prior to the procedure conclusion (n=1)</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Asthma exacerbation</sub_title>
                <description>Postoperative asthma exacerbation requiring emergency room care</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Intraoperative bradycardia</sub_title>
                <description>Bradycardia that required additional medication. Occurred after anesthesia but prior to the start of the surgical procedure. Not thought to be related to study intervention.</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea and vomiting, diarrhea</sub_title>
                <description>Postoperative nausea and vomiting and diarrhea on that required observation and medication administration. Not thought to be related to study intervention.</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Fever</sub_title>
                <description>Presented to emergency room with low grade fever of 100.4 Fahrenheit. Complete evaluation with no evidence of infection or other source of fever. No treatment or intervention required. Not thought to be related to study intervention.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Yeast Infection</sub_title>
                <description>Vulvar yeast infection requiring medication. Not thought to be related to study intervention.</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Wound infection</sub_title>
                <description>Postoperative malodorous discharge and fever presumed wound infection (no culture obtained). Treated with antibiotics with symptom resolution. Not thought to be related to study intervention.</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <description>Fell at home one week after surgery requiring evaluation in emergency room. Not thought to be related to study intervention.</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Excess postoperative surgical pain</sub_title>
                <description>Excessive postoperative surgical site pain that required additional visits and medications</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Leg numbness</sub_title>
                <description>Transient lower extremity numbness requiring extended observation and ultimately resolved spontaneously</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <description>Postoperative urinary tract infection defined as positive urine culture with symptoms</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Lauren Giugale, PI</name_or_title>
      <organization>Magee-Womens Hospital of UPMC</organization>
      <phone>412-641-1498</phone>
      <email>giugalele@upmc.edu</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03040011
org study id: PRO16110378
nct id: NCT03040011
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
To test the hypothesis that preoperative injections along the levator ani muscles and
      pudendal nerve with bupivacaine and dexamethasone improve pain control after vaginal apical
      reconstructive surgery. A three-arm, double-blinded, randomized controlled trial of a total
      of 75 women will be performed.

      The study population will be adult women (>18 years of age) with uterovaginal or vaginal
      vault prolapse who have been scheduled for native tissue vaginal reconstructive surgery which
      includes an apical support procedure. Participants will be enrolled prior to surgery. The
      procedure will involved four injection sites: the bilateral levator ani muscles via a
      transobturator approach and bilateral pudendal nerves via a transvaginal approach. Random
      assignment will occur to one of three study arms: combined arm (20 milliliters
      bupivacaine/dexamethasone solution divided between the 4 injection sites), bupivacaine arm
      (20 milliliters bupivacaine divided between the 4 injection sites), or placebo arm (20
      milliliters saline divided between the 4 injection sites).
The primary purpose of this three arm, randomized clinical trial is to test the hypothesis
      that preoperative injections along the levator ani muscles and pudendal nerve with
      bupivacaine and dexamethasone improve pain control after vaginal native tissue apical
      reconstructive surgery.

      Hypothesis: concurrent bilateral transobturator levator ani muscle injections and
      transvaginal pudendal nerve blocks with bupivacaine and dexamethasone performed prior to
      vaginal apical support procedures will result in improved pain scores at 24 hours
      postoperatively.

      Participants will be randomized to three arms: bupivacaine/dexamethasone group, bupivacaine
      group, and placebo group. Block randomization will occur and will be stratified by surgery
      type to ensure that similar numbers of each procedure are randomized to each study arm.

      All 3 groups will receive pudendal nerve blocks and transobturator levator ani muscle
      injections as outlined in detail below (with either bupivacaine/dexamethasone, bupivacaine
      alone or saline depending on randomization). The interventions will be performed after the
      participant is positioned in lithotomy position and after sterile preparation of the vagina
      and perineum per standard protocol. These injections will be performed at the start of the
      procedure prior to any vaginal repair and be administered by either the attending surgeon or
      the urogynecology fellow. After the interventions below, the vaginal reconstructive
      procedures will be performed as usual by the attending surgeon and surgical team. There are
      both fellows and residents who participate in these vaginal reconstructive surgeries, however
      for study purposes, resident physicians will not be permitted to administer either the
      pudendal nerve block or the transobturator injections. There are four attending surgeons and
      four fellow physicians who will be administering the injections. While all surgeons are
      familiar with the anatomy and have performed these procedures, each physician will be
      instructed on the intended procedures and additionally will be directly observed in the
      operating room for at least one procedure to ensure consistency in technique. All
      participants will undergo a standardized general anesthesia regimen.

      After the study intervention, all participants will then undergo the scheduled vaginal
      reconstructive procedure as standard. Infiltration of the vaginal epithelium with lidocaine
      is common in vaginal repairs. The maximum doses of lidocaine and bupivacaine are additive.
      The amount of local infiltration to 50 milliliters of 0.5% lidocaine with epinephrine. This
      dose is equal to 250mg of lidocaine which, when also taking into account the 50mg of
      bupivacaine, is within a safe dosing range for a participant weighing 50kg.

      Administration of all four injections involved in the study protocol and described above take
      approximately 5 additional minutes in total at the start of the case. After the injections
      are performed, there will be no further interventions.

      Other assessments that will be performed as part of the study protocol are outlined below:

      Baseline assessments: Pain assessment, assessment of presence of any baseline nausea or
      vomiting, baseline activities assessment will all be performed in preoperative area on the
      day of surgery prior to randomization.

      Postoperative pain score assessment: 3 hours, 24 hours, 48 hours, 72 hours, and 1 week
      postoperatively. Postoperative pain measured by the numerical rating scale (NRS). The NRS is
      a publicly available pain assessment tool that consists of an eleven point scale ranging from
      0 to 10 (0 = no pain and 10 = worst possible pain) presented visually on a horizontal line.
      Participants are asked to report a number or mark on the scale. Previous studies have
      demonstrated its reliability, validity and ease of administration. The NRS was chosen because
      a systematic review article demonstrated higher compliance rates, better responsiveness and
      ease of use relative to visual analog scales. Additionally, the NRS has been shown to have
      strong validity and low error rates when used in an elderly (>60 years) postoperative patient
      population.

      Postoperative nausea and vomiting assessment: 3 hours postoperatively The intensity of
      postoperative nausea and vomiting (PONV) using the PONV Intensity scale. The PONV scale is a
      four question assessment designed to measure clinically significant nausea and vomiting. It
      was initially validated in a general surgery population and has been validated in early
      postoperative gynecology patients. Clinically important nausea and vomiting is defined as a
      score greater than or equal to 50. This scale takes approximately 1 minute to complete and is
      publicly available. The amount of inpatient anti-emetic consumption will also be assessed.
      Any anti-emetic administered from surgery end time will be recorded as well as the dosage.
      Anti-emetic type and dosage will be recorded until the time of discharge.

      Voiding status at time of foley catheter removal. All patients routinely have some assessment
      of voiding function prior to discharge. Whether each participant passed or failed a voiding
      trial after surgery will be recorded in the database. If a participant fails, the standard of
      care is do be discharged to home after learning self-catheterization or with a foley
      catheter. In the event that a participant fails a postoperative voiding trial, whether
      participants receive a foley catheter or were performing self-catheterization will be
      recorded. As this is a routine part of postoperative care, the research protocol will not
      interfere with the performance or outcomes of a voiding trial. Results will be documented,
      however no specific assessment tool will be used.

      Time to resume normal activities measured by the activities assessment scale (AAS): 1 week, 2
      weeks, 6 weeks and 12 weeks postoperatively The AAS was initially designed to assess
      functional activity in the perioperative period in the general surgery population. It has
      since been deemed a valid and reliable measure to assess postoperative activity level in a
      Female Pelvic Medicine and Reconstructive Surgery patient population. It has the ability to
      measure perioperative function and takes approximately 3-5 minutes to complete. It consists
      of a 13 item questionnaire assessing various types of physical activity and the degree of
      difficulty associated with each activity. The types of activities assessed fall into three
      subscales: sedentary activities (questions 1-4), ambulatory activities (questions 6-8), and
      work or exercise activities (questions 11-13). Respondents also have the option to indicate
      that these activities were not performed for another indication (this item is not scored).
      The time frame for all questions is the previous 24 hours. Given that many patients are
      instructed to avoid strenuous work or exercise activity in the postoperative period, the
      subscales of sedentary activities and ambulatory activities, which patients are encouraged to
      perform as tolerated in the postoperative period, will be of most interest.

      Consumption of analgesic medications: during inpatient hospital stay and for first 72 hours
      postoperatively Narcotic consumption will be measured in morphine equivalents. The amount of
      narcotics will be obtained from the inpatient hospital record. All narcotics received from
      the surgery end time to the time of discharge will be included. Morphine equivalents will be
      calculated with online calculator available at
      http://www.agencymeddirectors.wa.gov/Calculator/DoseCalculator.htm. Similarly, the amount of
      NSAIDs will be obtained from the inpatient hospital record. All NSAIDs received from the
      surgery end time to the time of discharge will be included. To assess both the amount of
      narcotic and NSAID consumption after discharge, the participant will be provided with a diary
      form to record how many daily tablets of narcotic and NSAIDs are taken. This form will be
      completed from postoperative days 1-3.

      For all forms, the participants will be instructed to mail the forms back to the office once
      completed (in a pre-address envelope provided as part of the study). Participants will also
      have the option of brining the forms in to the office at the time of a participant's
      postoperative visit.

      Participants, physicians and any nursing personnel involved in patient care will remain
      masked until 12 weeks postoperatively.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Three-arm, double-blinded, placebo-controlled, randomized controlled trial
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Double-blinded
measure: Primary Postoperative Pain Measured by the Numerical Rating Scale (NRS)
time frame: 24 hours postoperatively
description: Postoperative pain measured by the numerical rating scale (NRS) at 24 hours postoperatively. The Numeric Rating Scale is an 11 point scale ranging from 0-10 with higher scores indicating worse pain.
measure: 6 Hour Postoperative Pain Measured by the NRS
time frame: 6 hours postoperatively
description: Postoperative pain as measured by the NRS at 6 hours after surgery. The Numeric Rating Scale is an 11 point scale ranging from 0-10 with higher scores indicating worse pain.
Of note, there is a typographical error in the protocol section and refers to this outcome as a NRS score at 3 hours postoperatively. The final IRB approved protocol is a 6 hour postoperative timepoint and this is the correct outcome reported here in the results section.
measure: POD 2 Postoperative Pain Measured by the NRS
time frame: 2 days after surgery
description: Postoperative Pain Measured by the NRS 2 days after surgery. The Numeric Rating Scale is an 11 point scale ranging from 0-10 with higher scores indicating worse pain.
measure: POD 3 Postoperative Pain Measured by the NRS
time frame: 3 days after surgery
description: Postoperative Pain Measured by the NRS 3 days after surgery. The Numeric Rating Scale is an 11 point scale ranging from 0-10 with higher scores indicating worse pain.
measure: 1 Week Postoperative Pain Measured by the NRS
time frame: 1 week after surgery
description: Postoperative Pain Measured by the Numeric Rating Scale 1 week after surgery. The Numeric Rating Scale is an 11 point scale ranging from 0-10 with higher scores indicating worse pain.
measure: Proportion of Patients With Same Day Discharge
time frame: Day of surgery
description: Same day discharge was defined as a patient being discharged on the same day as surgery and did not require an admission after surgery. The proportion of patients who were discharged on the day of surgery was compared between groups.
measure: Postoperative Urinary Retention
time frame: 0-24 hours postoperatively
description: Urinary retention was defined as the need to perform self-catheterization or have an indwelling catheter placed postoperatively. The proportion of patients with urinary retention was compared between groups.
measure: Adverse Events
time frame: 0-12 weeks postoperatively
description: The number of adverse events in each study group was assessed and compared between study groups. An adverse event was described as any medical or surgical complication that occurred either intraoperatively or postoperatively.
measure: Nausea and Vomiting Measured by the PONV Scale
time frame: 6 hours postoperatively
description: Intensity of postoperative nausea and vomiting (PONV) measured by the PONV scale prior to discharge. The Postoperative Nausea and Vomiting Intensity Scale is a four-question assessment to measure clinically significant nausea and vomiting with a range from 0-7 with higher scores signifying more clinically significant nausea and vomiting.
measure: Anti-emetic Consumption
time frame: 3 hours postoperatively
description: The amount of inpatient anti-emetic consumption, recorded in number of doses of nausea medication
measure: Return to Baseline Activities Using the Activities Assessment Scale
time frame: 1 week postoperative
description: Resumed normal daily activities using the Activities Assessment Scale (AAS) by 1 week after surgery. The AAS is a 13-point scale on which patients rate their difficulty performing a range of activities from "No difficulty" to "Not able to do it." A final score ranging from 0-100 is transformed, with higher numbers reflecting less difficulty with activities.
We defined return to normal as when a patient's postoperative AAS scores was at or greater than the baseline AAS score. We report the proportion of patients in each study arm who returned to baseline activity at each timepoint.
measure: Return to Baseline Activities Using the Activities Assessment Scale
time frame: 2 week postoperative
description: Resumed normal daily activities using the Activities Assessment Scale (AAS) by 2 weeks after surgery. The AAS is a 13-point scale on which patients rate their difficulty performing a range of activities from "No difficulty" to "Not able to do it." A final score ranging from 0-100 is transformed, with higher numbers reflecting less difficulty with activities.
We defined return to normal as when a patient's postoperative AAS scores was at or greater than the baseline AAS score. We report the proportion of patients in each study arm who returned to baseline activity at each timepoint.
measure: Return to Baseline Activities Using the Activities Assessment Scale
time frame: 6 weeks postoperative
description: Resumed normal daily activities using the Activities Assessment Scale (AAS) by 6 weeks after surgery. The AAS is a 13-point scale on which patients rate their difficulty performing a range of activities from "No difficulty" to "Not able to do it." A final score ranging from 0-100 is transformed, with higher numbers reflecting less difficulty with activities.
We defined return to normal as when a patient's postoperative AAS scores was at or greater than the baseline AAS score. We report the proportion of patients in each study arm who returned to baseline activity at each timepoint.
measure: Return to Baseline Activities Using the Activities Assessment Scale
time frame: 12 weeks postoperative
description: Resumed normal daily activities using the Activities Assessment Scale (AAS) by 12 weeks after surgery. The AAS is a 13-point scale on which patients rate their difficulty performing a range of activities from "No difficulty" to "Not able to do it." A final score ranging from 0-100 is transformed, with higher numbers reflecting less difficulty with activities.
We defined return to normal as when a patient's postoperative AAS scores was at or greater than the baseline AAS score. We report the proportion of patients in each study arm who returned to baseline activity at each timepoint.
measure: POD 1 Narcotic Consumption
time frame: Postoperative day 1
description: The total amount of narcotic pain medication used on postoperative day 1 was calculated and measured in oral morphine equivalents.
measure: POD 2 Narcotic Consumption
time frame: Postoperative day 2
description: The total amount of narcotic pain medication used on postoperative day 2 was calculated and measured in oral morphine equivalents.
measure: POD 3 Narcotic Consumption
time frame: Postoperative day 3
description: The total amount of narcotic pain medication used on postoperative day 3 was calculated and measured in oral morphine equivalents.
measure: POD 1 Ibuprofen Consumption
time frame: Postoperative day 1
description: The total amount of ibuprofen medication used on postoperative day 1.
measure: POD 2 Ibuprofen Consumption
time frame: Postoperative day 2
description: The total amount of ibuprofen medication used on postoperative day 2.
measure: POD 3 Ibuprofen Consumption
time frame: Postoperative day 3
description: The total amount of ibuprofen medication used on postoperative day 3.
arm group label: Bupivacaine/Dexamethasone Arm
arm group type: Experimental
description: After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen (transobturator). After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites.
arm group label: Bupivacaine Arm
arm group type: Active Comparator
description: After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen (transobturator). After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.25% bupivacaine (2.5mg/milliliter). The total amount will be divided equally between the four injection sites.
arm group label: Placebo Arm
arm group type: Placebo Comparator
description: After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen (transobturator). After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.9% saline (normal saline). The total amount will be divided equally between the four injection sites.
intervention type: Drug
intervention name: Dexamethasone
description: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.
arm group label: Bupivacaine/Dexamethasone Arm
other name: Decadron
intervention type: Drug
intervention name: Bupivacaine
description: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.
arm group label: Bupivacaine Arm
arm group label: Bupivacaine/Dexamethasone Arm
other name: Marcaine
intervention type: Procedure
intervention name: Bilateral Pudendal Nerve Block
description: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm medial and inferior to the ischial spine. When the needle guide is properly positioned, the spinal needle is advanced approximately 1cm through the vaginal mucosa into the sacrospinous ligament. The needle will be aspirated to ensure no intravascular needle placement. With a negative aspirate, 5 milliliters of solution are injected. This same procedure will be performed on the contralateral side.
arm group label: Bupivacaine Arm
arm group label: Bupivacaine/Dexamethasone Arm
arm group label: Placebo Arm
intervention type: Procedure
intervention name: Bilateral Levator Ani Muscle Injection
description: Performed transperineally. With thumb, superomedial aspect of obturator foramen is palpated 2-3 cm lateral to the clitoris. The index and middle finger are in the vagina to confirm obturator foramen. A spinal needle is inserted through the the obturator foramen into the obturator internus muscle. The needle is angled slightly posteriorly towards the ischial spine, parallel to the arcus tendineus levator ani and arcus tendineus fascia pelvis. The needle is advanced to the level of the ischial spine, the vaginal hand ensuring that the needle has not perforated the vaginal wall. Once the needle tip is at a depth of the ischial spine, aspiration is performed to ensure no intravascular needle placement. 5 milliliters of solution is injected along the length of the needle tract.
arm group label: Bupivacaine Arm
arm group label: Bupivacaine/Dexamethasone Arm
arm group label: Placebo Arm
intervention type: Drug
intervention name: Saline
description: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.
arm group label: Placebo Arm
other name: Normal Saline
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Lauren Giugale, MD
role: Principal Investigator
affiliation: University of Pittsburgh
facility: 
country: United States
citation: Dexamethasone (systemic): Drug information. UpToDate; 2016. Accessed November 9, 2016.
citation: Bupivacaine: Drug Information. UpToDate; 2016.
citation: Hsu D. Infiltration of local anesthetics. UpToDate. 2016. Accessed November 30, 2016.
responsible party type: Sponsor-Investigator
investigator affiliation: University of Pittsburgh
investigator full name: Lauren Giugale, MD
investigator title: MD
mesh term: Pain, Postoperative
mesh term: Prolapse
mesh term: Pelvic Organ Prolapse
mesh term: Dexamethasone
mesh term: Bupivacaine
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 