<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/NCT03027661</url>
  </required_header>
  <id_info>
    <org_study_id>16-130</org_study_id>
    <nct_id>NCT03027661</nct_id>
  </id_info>
  <brief_title>Para-cervical Block Prior to Laparoscopic Hysterectomy as an Adjuvant Treatment to Reduce Postoperative Pain.</brief_title>
  <official_title>Para-cervical Block Prior to Laparoscopic Hysterectomy as an Adjuvant Treatment to Reduce Postoperative Pain.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Tennessee</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Tennessee</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective randomized controlled trial in which patients that are scheduled to&#xD;
      undergo a laparoscopic hysterectomy would be allocated to one of two groups: Paracervical&#xD;
      block with local anesthetic (bupivacaine 0.5%), or placebo. This would be achieved using&#xD;
      block randomization. The intervention would be performed after the patient is under general&#xD;
      anesthesia, prior to starting the surgery. Patients would be consented in the office or&#xD;
      preoperative area (before receiving sedatives). As far as the intervention itself, it would&#xD;
      consist of injecting 5 mL of 0.5% bupivacaine into the cervical stroma at 3 and 9 o'clock,&#xD;
      which is standard technique for para-cervical block. The remainder of the procedure will then&#xD;
      continue in a regular fashion. Alternatively, patients in the control group will be injected&#xD;
      with 5 mL of normal saline. The surgeon would be blinded as to patient allocation. Research&#xD;
      staff will have previously prepared the formulations (saline or bupivacaine) and have sent&#xD;
      them to the operating room prior to beginning the procedure depending on assigned group. At&#xD;
      the end of the case, pain will be assessed using a visual analogue scale with a range from 0&#xD;
      to 10 by one of the researches who will also be blinded to the group. This will be done at 30&#xD;
      and 60 minutes after surgical stop time. Additional pain control in the postanesthesia care&#xD;
      unit (PACU) will be standardized to all patients.&#xD;
&#xD;
      Hypothesis:&#xD;
&#xD;
      Performing a para-cervical block with local anesthetic prior to a laparoscopic hysterectomy&#xD;
      significantly reduces pain after the procedure&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Specific aims:&#xD;
&#xD;
      -Determine if infiltrating the cervical stroma with local anesthetic prior to performing a&#xD;
      hysterectomy will reduce postoperative pain scores, and hence increase patient satisfaction.&#xD;
&#xD;
      Secondary aims:&#xD;
&#xD;
        -  Determine if there is a difference in baseline pain depending on additional procedures&#xD;
           performed, and their response to the paracervical block.&#xD;
&#xD;
        -  Determine if there is a difference in response to paracervical block based on history of&#xD;
           cesarean deliveries or uterine weight.&#xD;
&#xD;
      Background/Significance:&#xD;
&#xD;
      Hysterectomy is one of the most common surgical procedures performed in the United States,&#xD;
      with more than 600,000 done annually. Over the last decade, there has been major changes in&#xD;
      regards to the surgical approach utilized. With the advent of laparoscopy and robotic&#xD;
      surgery, the rate of procedures done vaginally or abdominally has decreased significantly.&#xD;
      One of the major drivers to this change is the demand for a faster recovery and decreased&#xD;
      postoperative discomfort. Additionally, several adjuvant methods such as a TAP (transverse&#xD;
      abdominal plain) block, ERAS (expedited recovery after surgery) pathway, etc. have been&#xD;
      developed in order to minimize pain after surgery and hence increase patient satisfaction.&#xD;
      Paracervical block is a particular technique that has been evaluated in multiple studies as a&#xD;
      way to reduce pain after vaginal surgery. Studies have been successful in demonstrating an&#xD;
      improvement in pain scores after these types of procedures. However, to our knowledge, there&#xD;
      has never been follow-up to evaluate this method during the laparoscopic approach, with or&#xD;
      without robotic assistance. The rationale of why this technique may be beneficial during a&#xD;
      hysterectomy is that after infiltrating the cervical stroma with local anesthetic, it will&#xD;
      diffuse towards the pelvic sidewalls via the lymphatic and capillary systems, which would&#xD;
      allow for the anesthetic agent to come in direct contact with the nerve plexuses that&#xD;
      innervate the pelvic structures. Safety of the technique has been proven over the years,&#xD;
      given that it is widely used during office procedures that involve manipulation of the&#xD;
      cervix. Although much of the focus regarding reducing postoperative pain has been centered on&#xD;
      the abdominal wall and port sites, it is undeniable that a significant portion of pain&#xD;
      actually arises from the pelvic surgical site; particularly since laparoscopic trocars have&#xD;
      become smaller, resulting in less trauma. Our aim is to determine if infiltrating the&#xD;
      cervical stroma with local anesthetic prior to performing a hysterectomy will reduce&#xD;
      postoperative pain scores, and hence increase patient satisfaction.&#xD;
&#xD;
      Methods&#xD;
&#xD;
      Study design&#xD;
&#xD;
      This is a prospective randomized controlled trial in which patients that are scheduled to&#xD;
      undergo a laparoscopic hysterectomy would be allocated to one of two groups: Paracervical&#xD;
      block with local anesthetic (bupivacaine 0.5%), or placebo. This would be achieved using&#xD;
      block randomization. The intervention would be performed after the patient is under general&#xD;
      anesthesia, prior to starting the surgery. Patients would be consented in the office or&#xD;
      preoperative area (before receiving sedatives). As far as the intervention itself, it would&#xD;
      consist of injecting 10 mL of 0.5% bupivacaine into the cervical stroma at 3 and 9 o'clock,&#xD;
      which is standard technique for para-cervical block. The remainder of the procedure will then&#xD;
      continue in a regular fashion. Alternatively, patients in the control group will be injected&#xD;
      with 10 mL of normal saline. The surgeon would be blinded as to patient allocation. The&#xD;
      formulations (saline or bupivacaine) will be previously prepared in a syringe in the&#xD;
      operating room by a member of the research time prior to beginning the procedure. At the end&#xD;
      of the case, pain will be assessed using a visual analogue scale with a range from 0 to 10&#xD;
      (Wong-Baker faces - appendix 1) by one of the researches who will also be blinded to the&#xD;
      group. This will be done at 30 and 60 minutes after surgical stop time. Additional pain&#xD;
      control in the PACU will be standardized to all patients.&#xD;
&#xD;
      Study Subjects&#xD;
&#xD;
      Subjects will be selected based mainly on the fact they are undergoing a hysterectomy.&#xD;
&#xD;
      Sample Size&#xD;
&#xD;
      Investigators expect to detect a 25% reduction in pain reported on the visual analogue scale&#xD;
      (VAS). Based on previous publications, it was determined that the mean VAS pain score after a&#xD;
      laparoscopic hysterectomy is 5 with a standard deviation of 1.5. In order to detect the&#xD;
      expected change after the proposed intervention, with a significance level of 5% and a power&#xD;
      of 80%, a sample of 46 patients is required.&#xD;
&#xD;
      Data Collection&#xD;
&#xD;
      Data points to be collected are as follows:&#xD;
&#xD;
        -  Age&#xD;
&#xD;
        -  BMI&#xD;
&#xD;
        -  Operating time&#xD;
&#xD;
        -  History of cesarean deliveries&#xD;
&#xD;
        -  Preoperative indication for surgery (pain, prolapse, tumor, bleeding, etc)&#xD;
&#xD;
        -  Procedures performed (if ovaries/tubes were removed, if robotic assistance was used, if&#xD;
           any additional procedures that are exceptions from the exclusion criteria were&#xD;
           performed).&#xD;
&#xD;
        -  Specimen weight&#xD;
&#xD;
        -  Uterine pathology&#xD;
&#xD;
        -  Pain score at 30 minutes (see appendix 1 for Wong-Baker scale)&#xD;
&#xD;
        -  Pain score at 60 minutes&#xD;
&#xD;
        -  Number of days in the hospital (zero if discharged on same-day)&#xD;
&#xD;
      Data Handling&#xD;
&#xD;
      A master key will be generated during randomization. It will contain patient initials and&#xD;
      medical record number, and an individual code. Only the primary investigator will have access&#xD;
      to this master key. A separate de-identified database using the individual code as index will&#xD;
      be used for collection of all data points. The data that can be collected on the day of&#xD;
      surgery (baseline characteristics, operating time, pain scores, etc) will be collected that&#xD;
      day using a standardized form (appendix 2). This will later be transferred to the&#xD;
      de-identified database. Using the master key, investigators will research pathology reports&#xD;
      when available to complete final data points (uterine weight, histology, etc).&#xD;
&#xD;
      The data-collection sheets will be destroyed as soon as they are transferred into the&#xD;
      de-identified database.&#xD;
&#xD;
      Data Analysis&#xD;
&#xD;
      Investigators will use T-Student tests to assure groups are homogenous to age, BMI, operating&#xD;
      time, history of cesarean deliveries, and uterine weight. ChiSquare and Ancova analysis will&#xD;
      be utilized to determine if there is a significant difference in reported pain scores between&#xD;
      groups. Investigators will also stratify subjects based on uterine weight, history of&#xD;
      cesarean delivery, additional procedures, etc. and determine if this has an effect on the&#xD;
      reported pain scores.&#xD;
&#xD;
      Time Frame&#xD;
&#xD;
      Investigators expect to be able to consent and enroll at least two patients per week (average&#xD;
      range of hysterectomy procedures per week from the surgeons that will participate is 5-10).&#xD;
      Investigators expect the data collection phase to span over 30 weeks approximately.&#xD;
&#xD;
      Strength/Innovation&#xD;
&#xD;
      Patient satisfaction is a center point in today's healthcare. Faster recovery with less&#xD;
      discomfort is not only standard of care, but may also translate into major economic&#xD;
      advantages, such as less narcotic use and a decreased rate of postoperative admission. Using&#xD;
      this technique as an adjuvant treatment for pain after laparoscopic hysterectomies has never&#xD;
      been explored. There is data published for similar procedures, which demonstrates a clear&#xD;
      benefit. If this study demonstrates significant improvement in pain scores, it has the&#xD;
      potential to change standard of care for pain control during hysterectomy procedures.&#xD;
&#xD;
      Limitations&#xD;
&#xD;
      The main confounding factors are difference in operating style between surgeons and baseline&#xD;
      surgical characteristics (large uteri that may require more dissection and tissue&#xD;
      manipulation, etc.). To control for this investigators are only recruiting patients from 3&#xD;
      surgeons who have a similar operating technique. In addition to this, investigators are&#xD;
      documenting operating time and specimen weight, which can be used to compare both groups and&#xD;
      assure that they are homogeneous to these potential confounders. Further analysis will also&#xD;
      be made specifically stratifying the data based on these characteristics.&#xD;
&#xD;
      Risks&#xD;
&#xD;
      The risks of the procedure are minimal. Regarding possible adverse reactions to the local&#xD;
      anesthetic, there is no additional risk given that this is already routinely administered&#xD;
      during surgery. Patients will be screened to confirm they do not have a history of allergies&#xD;
      to the medication. Possible reactions include hypotension, bradycardia, headaches, tremors,&#xD;
      etc. The paracervical block is routinely performed in the office setting before most invasive&#xD;
      procedures involving the cervix, and risks are minimal, similar to those involving any&#xD;
      subdermal injection. Possible risks include bleeding from injection site.&#xD;
&#xD;
      There is also the potential risk of accidental disclosure of the health information that will&#xD;
      be collected.&#xD;
&#xD;
      Benefits&#xD;
&#xD;
      This study may find new methods of improving postoperative analgesia for patients undergoing&#xD;
      minimally invasive hysterectomy procedures which may lead to less narcotic use, faster&#xD;
      discharge from hospital, and greater satisfaction.&#xD;
&#xD;
      Costs&#xD;
&#xD;
      There is no additional costs. Local anesthetic and saline are products that are routinely&#xD;
      used during all laparoscopic hysterectomy surgeries. The additional operating time it would&#xD;
      take to perform the block is also negligible, since it is a procedure that can be&#xD;
      accomplished in less than 2 minutes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Actual">June 30, 2018</completion_date>
  <primary_completion_date type="Actual">June 30, 2018</primary_completion_date>
  <phase>Phase 3</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain Reported on the Visual Analogue Scale (VAS) at 30 Minutes Postoperative</measure>
    <time_frame>30 minutes post-operative stop time</time_frame>
    <description>Scale used is the Visual analogue scale for pain. Scale ranges from 0 being no pain, to 10 being worse pain ever experienced.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain Reported on the Visual Analogue Scale (VAS) at 60 Minutes Postoperative</measure>
    <time_frame>60 minutes</time_frame>
    <description>Postoperative pain score on the Visual analgoue scale at 60 minutes from surgical stop time. Scale ranges from 0 being no pain, to 10 being worse pain ever experienced.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">41</enrollment>
  <condition>Pain, Postoperative</condition>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Injection of 10 mL of 0.9% sodium chloride into the cervical stroma divided between 3 and 9 o'clock</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Study Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Injection of 10 mL of 0.5% bupivacaine into the cervical stroma divided between 3 and 9 o'clock.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupivacaine</intervention_name>
    <description>Inject 10 mL of 0.5% bupivacaine into cervical stroma</description>
    <arm_group_label>Study Group</arm_group_label>
    <other_name>Marcaine</other_name>
    <other_name>Sensorcaine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>0.9% Sodium Chloride</intervention_name>
    <description>Inject 10 mL of 0.9% NaCl into cervical stroma</description>
    <arm_group_label>Control Group</arm_group_label>
    <other_name>Normal Saline</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Undergoing laparoscopic hysterectomy with or without salpingoophorectomy for benign&#xD;
             indications&#xD;
&#xD;
          -  Undergoing laparoscopic hysterectomy with robotic assistance with or without&#xD;
             salpingoophorectomy for benign indications&#xD;
&#xD;
          -  Between 18 and 60 years of age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Intraoperative detection of malignancy&#xD;
&#xD;
          -  Undergoing additional procedures at the time of surgery (except prophylactic McCall&#xD;
             culdoplasty/uterosacral ligament suspension, excision of endometriosis, appendectomy,&#xD;
             cystoscopy)&#xD;
&#xD;
          -  Inability to perform paracervical block due to anatomic abnormalities (absent/flush&#xD;
             cervix)&#xD;
&#xD;
          -  Known allergy/sensitivity to bupivacaine&#xD;
&#xD;
          -  Intraoperative bowel injury, bladder injury, ureter injury or major vessel injury that&#xD;
             required repair.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Steven J Radtke, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UT College of Medicine MIGS Fellow &amp; Faculty</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Erlanger Medical Center</name>
      <address>
        <city>Chattanooga</city>
        <state>Tennessee</state>
        <zip>37403</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Acton JN, Salfinger SG, Tan J, Cohen PA. Outcomes of Total Laparoscopic Hysterectomy Using a 5-mm Versus 10-mm Laparoscope: A Randomized Control Trial. J Minim Invasive Gynecol. 2016 Jan;23(1):101-6. doi: 10.1016/j.jmig.2015.09.001. Epub 2015 Sep 11.</citation>
    <PMID>26371370</PMID>
  </reference>
  <reference>
    <citation>Centini G, Calonaci A, Lazzeri L, Tosti C, Palomba C, Puzzutiello R, Luisi S, Petraglia F, Zupi E. Parenterally administered moderate sedation and paracervical block versus general anesthesia for hysteroscopic polypectomy: a pilot study comparing postoperative outcomes. J Minim Invasive Gynecol. 2015 Feb;22(2):193-8. doi: 10.1016/j.jmig.2014.09.008. Epub 2014 Nov 13.</citation>
    <PMID>25265887</PMID>
  </reference>
  <reference>
    <citation>Donnez O, Donnez J, Dolmans MM, Dethy A, Baeyens M, Mitchell J. Low Pain Score After Total Laparoscopic Hysterectomy and Same-Day Discharge Within Less Than 5 Hours: Results of a Prospective Observational Study. J Minim Invasive Gynecol. 2015 Nov-Dec;22(7):1293-9. doi: 10.1016/j.jmig.2015.06.021. Epub 2015 Jul 11.</citation>
    <PMID>26169246</PMID>
  </reference>
  <reference>
    <citation>Golembiewski J, Dasta J. Evolving Role of Local Anesthetics in Managing Postsurgical Analgesia. Clin Ther. 2015 Jun 1;37(6):1354-71. doi: 10.1016/j.clinthera.2015.03.017. Epub 2015 Apr 10.</citation>
    <PMID>25866297</PMID>
  </reference>
  <reference>
    <citation>Long JB, Eiland RJ, Hentz JG, Mergens PA, Magtibay PM, Kho RM, Magrina JF, Cornella JL. Randomized trial of preemptive local analgesia in vaginal surgery. Int Urogynecol J Pelvic Floor Dysfunct. 2009 Jan;20(1):5-10. doi: 10.1007/s00192-008-0716-6. Epub 2008 Oct 2.</citation>
    <PMID>18830553</PMID>
  </reference>
  <reference>
    <citation>Ng A, Swami A, Smith G, Davidson AC, Emembolu J. The analgesic effects of intraperitoneal and incisional bupivacaine with epinephrine after total abdominal hysterectomy. Anesth Analg. 2002 Jul;95(1):158-62, table of contents. doi: 10.1097/00000539-200207000-00028.</citation>
    <PMID>12088961</PMID>
  </reference>
  <reference>
    <citation>O'Neal MG, Beste T, Shackelford DP. Utility of preemptive local analgesia in vaginal hysterectomy. Am J Obstet Gynecol. 2003 Dec;189(6):1539-41; discussion 1541-2. doi: 10.1016/j.ajog.2003.10.691.</citation>
    <PMID>14710057</PMID>
  </reference>
  <reference>
    <citation>Penninx JP, Mol BW, Bongers MY. Endometrial ablation with paracervical block. J Reprod Med. 2009 Oct;54(10):617-20.</citation>
    <PMID>20677480</PMID>
  </reference>
  <reference>
    <citation>Skensved H. Combining Paracervical Block With a Complete Fundal Block Significantly Reduces Patients' Perception of Pain During Radio-Frequency Endometrial Ablation in an Office Setting. J Minim Invasive Gynecol. 2015 Nov-Dec;22(6S):S45. doi: 10.1016/j.jmig.2015.08.124. Epub 2015 Oct 15. No abstract available.</citation>
    <PMID>27679246</PMID>
  </reference>
  <reference>
    <citation>Tangsiriwatthana T, Sangkomkamhang US, Lumbiganon P, Laopaiboon M. Paracervical local anaesthesia for cervical dilatation and uterine intervention. Cochrane Database Syst Rev. 2013 Sep 30;(9):CD005056. doi: 10.1002/14651858.CD005056.pub3.</citation>
    <PMID>24085642</PMID>
  </reference>
  <reference>
    <citation>ACOG Committee Opinion No. 444: choosing the route of hysterectomy for benign disease. Obstet Gynecol. 2009 Nov;114(5):1156-1158. doi: 10.1097/AOG.0b013e3181c33c72.</citation>
    <PMID>20168127</PMID>
  </reference>
  <reference>
    <citation>Wong-Baker FACES Foundation (2016). Wong-Baker FACES® Pain Rating Scale. Retrieved 11/10/2016 with permission from http://www.WongBakerFACES.org</citation>
  </reference>
  <reference>
    <citation>Mercier RJ, Zerden ML. Intrauterine anesthesia for gynecologic procedures: a systematic review. Obstet Gynecol. 2012 Sep;120(3):669-77. doi: 10.1097/AOG.0b013e3182639ab5.</citation>
    <PMID>22914480</PMID>
  </reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 17, 2017</study_first_submitted>
  <study_first_submitted_qc>January 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <results_first_submitted>August 7, 2018</results_first_submitted>
  <results_first_submitted_qc>October 16, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">November 15, 2018</results_first_posted>
  <last_update_submitted>October 16, 2018</last_update_submitted>
  <last_update_submitted_qc>October 16, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 15, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>para-cervical block</keyword>
  <keyword>laparoscopic hysterectomy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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>December 21, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/61/NCT03027661/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Control Group</title>
          <description>Injection of 10 mL of 0.9% sodium chloride into the cervical stroma divided between 3 and 9 o'clock&#xD;
0.9% Sodium Chloride: Inject 10 mL of 0.9% NaCl into cervical stroma</description>
        </group>
        <group group_id="P2">
          <title>Study Group</title>
          <description>Injection of 10 mL of 0.5% bupivacaine into the cervical stroma divided between 3 and 9 o'clock.&#xD;
Bupivacaine: Inject 10 mL of 0.5% bupivacaine into cervical stroma</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="21"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="21"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Control Group</title>
          <description>Injection of 10 mL of 0.9% sodium chloride into the cervical stroma divided between 3 and 9 o'clock&#xD;
0.9% Sodium Chloride: Inject 10 mL of 0.9% NaCl into cervical stroma</description>
        </group>
        <group group_id="B2">
          <title>Study Group</title>
          <description>Injection of 10 mL of 0.5% bupivacaine into the cervical stroma divided between 3 and 9 o'clock.&#xD;
Bupivacaine: Inject 10 mL of 0.5% bupivacaine into cervical stroma</description>
        </group>
        <group group_id="B3">
          <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="20"/>
            <count group_id="B2" value="21"/>
            <count group_id="B3" value="41"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</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="20"/>
                    <count group_id="B2" value="21"/>
                    <count group_id="B3" value="41"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="41"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <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="20"/>
                    <count group_id="B2" value="21"/>
                    <count group_id="B3" value="41"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="46.50" spread="9.8"/>
                    <measurement group_id="B2" value="46" spread="10.4"/>
                    <measurement group_id="B3" value="46.24" spread="10.0"/>
                  </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="20"/>
                    <count group_id="B2" value="21"/>
                    <count group_id="B3" value="41"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="41"/>
                  </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_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_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" 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="20"/>
                    <count group_id="B2" value="21"/>
                    <count group_id="B3" value="41"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI</title>
          <units>kg/m^2</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="20"/>
                    <count group_id="B2" value="21"/>
                    <count group_id="B3" value="41"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="35.05" spread="9.8"/>
                    <measurement group_id="B2" value="32.75" spread="9.8"/>
                    <measurement group_id="B3" value="33.87" spread="9.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>history of csection</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="20"/>
                    <count group_id="B2" value="21"/>
                    <count group_id="B3" value="41"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Pain Reported on the Visual Analogue Scale (VAS) at 30 Minutes Postoperative</title>
        <description>Scale used is the Visual analogue scale for pain. Scale ranges from 0 being no pain, to 10 being worse pain ever experienced.</description>
        <time_frame>30 minutes post-operative stop time</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Control Group</title>
            <description>Injection of 10 mL of 0.9% sodium chloride into the cervical stroma divided between 3 and 9 o'clock&#xD;
0.9% Sodium Chloride: Inject 10 mL of 0.9% NaCl into cervical stroma</description>
          </group>
          <group group_id="O2">
            <title>Study Group</title>
            <description>Injection of 10 mL of 0.5% bupivacaine into the cervical stroma divided between 3 and 9 o'clock.&#xD;
Bupivacaine: Inject 10 mL of 0.5% bupivacaine into cervical stroma</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Reported on the Visual Analogue Scale (VAS) at 30 Minutes Postoperative</title>
          <description>Scale used is the Visual analogue scale for pain. Scale ranges from 0 being no pain, to 10 being worse pain ever experienced.</description>
          <units>VAS scale 0-10</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.7" spread="2.8"/>
                    <measurement group_id="O2" value="3.2" spread="3.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pain Reported on the Visual Analogue Scale (VAS) at 60 Minutes Postoperative</title>
        <description>Postoperative pain score on the Visual analgoue scale at 60 minutes from surgical stop time. Scale ranges from 0 being no pain, to 10 being worse pain ever experienced.</description>
        <time_frame>60 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Control Group</title>
            <description>Injection of 10 mL of 0.9% sodium chloride into the cervical stroma divided between 3 and 9 o'clock&#xD;
0.9% Sodium Chloride: Inject 10 mL of 0.9% NaCl into cervical stroma</description>
          </group>
          <group group_id="O2">
            <title>Study Group</title>
            <description>Injection of 10 mL of 0.5% bupivacaine into the cervical stroma divided between 3 and 9 o'clock.&#xD;
Bupivacaine: Inject 10 mL of 0.5% bupivacaine into cervical stroma</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Reported on the Visual Analogue Scale (VAS) at 60 Minutes Postoperative</title>
          <description>Postoperative pain score on the Visual analgoue scale at 60 minutes from surgical stop time. Scale ranges from 0 being no pain, to 10 being worse pain ever experienced.</description>
          <units>VAS scale 0-10</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.9" spread="3.0"/>
                    <measurement group_id="O2" value="2.3" spread="2.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>30 days from enrollment</time_frame>
      <desc>Reaction to local anesthetic is the main adverse event expected. No adverse reactions were observed.</desc>
      <group_list>
        <group group_id="E1">
          <title>Control Group</title>
          <description>Injection of 10 mL of 0.9% sodium chloride into the cervical stroma divided between 3 and 9 o'clock&#xD;
0.9% Sodium Chloride: Inject 10 mL of 0.9% NaCl into cervical stroma</description>
        </group>
        <group group_id="E2">
          <title>Study Group</title>
          <description>Injection of 10 mL of 0.5% bupivacaine into the cervical stroma divided between 3 and 9 o'clock.&#xD;
Bupivacaine: Inject 10 mL of 0.5% bupivacaine into cervical stroma</description>
        </group>
      </group_list>
      <serious_events>
        <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="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
              </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>Elaine Todd, Director of Sponsored Programs - Contracts and research agreements</name_or_title>
      <organization>University of Tennessee Health and Science Center</organization>
      <phone>9014483303</phone>
      <email>ElaineTodd@uthsc.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/NCT03027661
org study id: 16-130
nct id: NCT03027661
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This is a prospective randomized controlled trial in which patients that are scheduled to
      undergo a laparoscopic hysterectomy would be allocated to one of two groups: Paracervical
      block with local anesthetic (bupivacaine 0.5%), or placebo. This would be achieved using
      block randomization. The intervention would be performed after the patient is under general
      anesthesia, prior to starting the surgery. Patients would be consented in the office or
      preoperative area (before receiving sedatives). As far as the intervention itself, it would
      consist of injecting 5 mL of 0.5% bupivacaine into the cervical stroma at 3 and 9 o'clock,
      which is standard technique for para-cervical block. The remainder of the procedure will then
      continue in a regular fashion. Alternatively, patients in the control group will be injected
      with 5 mL of normal saline. The surgeon would be blinded as to patient allocation. Research
      staff will have previously prepared the formulations (saline or bupivacaine) and have sent
      them to the operating room prior to beginning the procedure depending on assigned group. At
      the end of the case, pain will be assessed using a visual analogue scale with a range from 0
      to 10 by one of the researches who will also be blinded to the group. This will be done at 30
      and 60 minutes after surgical stop time. Additional pain control in the postanesthesia care
      unit (PACU) will be standardized to all patients.

      Hypothesis:

      Performing a para-cervical block with local anesthetic prior to a laparoscopic hysterectomy
      significantly reduces pain after the procedure
Specific aims:

      -Determine if infiltrating the cervical stroma with local anesthetic prior to performing a
      hysterectomy will reduce postoperative pain scores, and hence increase patient satisfaction.

      Secondary aims:

        -  Determine if there is a difference in baseline pain depending on additional procedures
           performed, and their response to the paracervical block.

        -  Determine if there is a difference in response to paracervical block based on history of
           cesarean deliveries or uterine weight.

      Background/Significance:

      Hysterectomy is one of the most common surgical procedures performed in the United States,
      with more than 600,000 done annually. Over the last decade, there has been major changes in
      regards to the surgical approach utilized. With the advent of laparoscopy and robotic
      surgery, the rate of procedures done vaginally or abdominally has decreased significantly.
      One of the major drivers to this change is the demand for a faster recovery and decreased
      postoperative discomfort. Additionally, several adjuvant methods such as a TAP (transverse
      abdominal plain) block, ERAS (expedited recovery after surgery) pathway, etc. have been
      developed in order to minimize pain after surgery and hence increase patient satisfaction.
      Paracervical block is a particular technique that has been evaluated in multiple studies as a
      way to reduce pain after vaginal surgery. Studies have been successful in demonstrating an
      improvement in pain scores after these types of procedures. However, to our knowledge, there
      has never been follow-up to evaluate this method during the laparoscopic approach, with or
      without robotic assistance. The rationale of why this technique may be beneficial during a
      hysterectomy is that after infiltrating the cervical stroma with local anesthetic, it will
      diffuse towards the pelvic sidewalls via the lymphatic and capillary systems, which would
      allow for the anesthetic agent to come in direct contact with the nerve plexuses that
      innervate the pelvic structures. Safety of the technique has been proven over the years,
      given that it is widely used during office procedures that involve manipulation of the
      cervix. Although much of the focus regarding reducing postoperative pain has been centered on
      the abdominal wall and port sites, it is undeniable that a significant portion of pain
      actually arises from the pelvic surgical site; particularly since laparoscopic trocars have
      become smaller, resulting in less trauma. Our aim is to determine if infiltrating the
      cervical stroma with local anesthetic prior to performing a hysterectomy will reduce
      postoperative pain scores, and hence increase patient satisfaction.

      Methods

      Study design

      This is a prospective randomized controlled trial in which patients that are scheduled to
      undergo a laparoscopic hysterectomy would be allocated to one of two groups: Paracervical
      block with local anesthetic (bupivacaine 0.5%), or placebo. This would be achieved using
      block randomization. The intervention would be performed after the patient is under general
      anesthesia, prior to starting the surgery. Patients would be consented in the office or
      preoperative area (before receiving sedatives). As far as the intervention itself, it would
      consist of injecting 10 mL of 0.5% bupivacaine into the cervical stroma at 3 and 9 o'clock,
      which is standard technique for para-cervical block. The remainder of the procedure will then
      continue in a regular fashion. Alternatively, patients in the control group will be injected
      with 10 mL of normal saline. The surgeon would be blinded as to patient allocation. The
      formulations (saline or bupivacaine) will be previously prepared in a syringe in the
      operating room by a member of the research time prior to beginning the procedure. At the end
      of the case, pain will be assessed using a visual analogue scale with a range from 0 to 10
      (Wong-Baker faces - appendix 1) by one of the researches who will also be blinded to the
      group. This will be done at 30 and 60 minutes after surgical stop time. Additional pain
      control in the PACU will be standardized to all patients.

      Study Subjects

      Subjects will be selected based mainly on the fact they are undergoing a hysterectomy.

      Sample Size

      Investigators expect to detect a 25% reduction in pain reported on the visual analogue scale
      (VAS). Based on previous publications, it was determined that the mean VAS pain score after a
      laparoscopic hysterectomy is 5 with a standard deviation of 1.5. In order to detect the
      expected change after the proposed intervention, with a significance level of 5% and a power
      of 80%, a sample of 46 patients is required.

      Data Collection

      Data points to be collected are as follows:

        -  Age

        -  BMI

        -  Operating time

        -  History of cesarean deliveries

        -  Preoperative indication for surgery (pain, prolapse, tumor, bleeding, etc)

        -  Procedures performed (if ovaries/tubes were removed, if robotic assistance was used, if
           any additional procedures that are exceptions from the exclusion criteria were
           performed).

        -  Specimen weight

        -  Uterine pathology

        -  Pain score at 30 minutes (see appendix 1 for Wong-Baker scale)

        -  Pain score at 60 minutes

        -  Number of days in the hospital (zero if discharged on same-day)

      Data Handling

      A master key will be generated during randomization. It will contain patient initials and
      medical record number, and an individual code. Only the primary investigator will have access
      to this master key. A separate de-identified database using the individual code as index will
      be used for collection of all data points. The data that can be collected on the day of
      surgery (baseline characteristics, operating time, pain scores, etc) will be collected that
      day using a standardized form (appendix 2). This will later be transferred to the
      de-identified database. Using the master key, investigators will research pathology reports
      when available to complete final data points (uterine weight, histology, etc).

      The data-collection sheets will be destroyed as soon as they are transferred into the
      de-identified database.

      Data Analysis

      Investigators will use T-Student tests to assure groups are homogenous to age, BMI, operating
      time, history of cesarean deliveries, and uterine weight. ChiSquare and Ancova analysis will
      be utilized to determine if there is a significant difference in reported pain scores between
      groups. Investigators will also stratify subjects based on uterine weight, history of
      cesarean delivery, additional procedures, etc. and determine if this has an effect on the
      reported pain scores.

      Time Frame

      Investigators expect to be able to consent and enroll at least two patients per week (average
      range of hysterectomy procedures per week from the surgeons that will participate is 5-10).
      Investigators expect the data collection phase to span over 30 weeks approximately.

      Strength/Innovation

      Patient satisfaction is a center point in today's healthcare. Faster recovery with less
      discomfort is not only standard of care, but may also translate into major economic
      advantages, such as less narcotic use and a decreased rate of postoperative admission. Using
      this technique as an adjuvant treatment for pain after laparoscopic hysterectomies has never
      been explored. There is data published for similar procedures, which demonstrates a clear
      benefit. If this study demonstrates significant improvement in pain scores, it has the
      potential to change standard of care for pain control during hysterectomy procedures.

      Limitations

      The main confounding factors are difference in operating style between surgeons and baseline
      surgical characteristics (large uteri that may require more dissection and tissue
      manipulation, etc.). To control for this investigators are only recruiting patients from 3
      surgeons who have a similar operating technique. In addition to this, investigators are
      documenting operating time and specimen weight, which can be used to compare both groups and
      assure that they are homogeneous to these potential confounders. Further analysis will also
      be made specifically stratifying the data based on these characteristics.

      Risks

      The risks of the procedure are minimal. Regarding possible adverse reactions to the local
      anesthetic, there is no additional risk given that this is already routinely administered
      during surgery. Patients will be screened to confirm they do not have a history of allergies
      to the medication. Possible reactions include hypotension, bradycardia, headaches, tremors,
      etc. The paracervical block is routinely performed in the office setting before most invasive
      procedures involving the cervix, and risks are minimal, similar to those involving any
      subdermal injection. Possible risks include bleeding from injection site.

      There is also the potential risk of accidental disclosure of the health information that will
      be collected.

      Benefits

      This study may find new methods of improving postoperative analgesia for patients undergoing
      minimally invasive hysterectomy procedures which may lead to less narcotic use, faster
      discharge from hospital, and greater satisfaction.

      Costs

      There is no additional costs. Local anesthetic and saline are products that are routinely
      used during all laparoscopic hysterectomy surgeries. The additional operating time it would
      take to perform the block is also negligible, since it is a procedure that can be
      accomplished in less than 2 minutes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Pain Reported on the Visual Analogue Scale (VAS) at 30 Minutes Postoperative
time frame: 30 minutes post-operative stop time
description: Scale used is the Visual analogue scale for pain. Scale ranges from 0 being no pain, to 10 being worse pain ever experienced.
measure: Pain Reported on the Visual Analogue Scale (VAS) at 60 Minutes Postoperative
time frame: 60 minutes
description: Postoperative pain score on the Visual analgoue scale at 60 minutes from surgical stop time. Scale ranges from 0 being no pain, to 10 being worse pain ever experienced.
arm group label: Control Group
arm group type: Placebo Comparator
description: Injection of 10 mL of 0.9% sodium chloride into the cervical stroma divided between 3 and 9 o'clock
arm group label: Study Group
arm group type: Active Comparator
description: Injection of 10 mL of 0.5% bupivacaine into the cervical stroma divided between 3 and 9 o'clock.
intervention type: Drug
intervention name: Bupivacaine
description: Inject 10 mL of 0.5% bupivacaine into cervical stroma
arm group label: Study Group
other name: Marcaine
other name: Sensorcaine
intervention type: Drug
intervention name: 0.9% Sodium Chloride
description: Inject 10 mL of 0.9% NaCl into cervical stroma
arm group label: Control Group
other name: Normal Saline
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Steven J Radtke, MD
role: Principal Investigator
affiliation: UT College of Medicine MIGS Fellow & Faculty
facility: 
country: United States
citation: Acton JN, Salfinger SG, Tan J, Cohen PA. Outcomes of Total Laparoscopic Hysterectomy Using a 5-mm Versus 10-mm Laparoscope: A Randomized Control Trial. J Minim Invasive Gynecol. 2016 Jan;23(1):101-6. doi: 10.1016/j.jmig.2015.09.001. Epub 2015 Sep 11.
PMID: 26371370
citation: Centini G, Calonaci A, Lazzeri L, Tosti C, Palomba C, Puzzutiello R, Luisi S, Petraglia F, Zupi E. Parenterally administered moderate sedation and paracervical block versus general anesthesia for hysteroscopic polypectomy: a pilot study comparing postoperative outcomes. J Minim Invasive Gynecol. 2015 Feb;22(2):193-8. doi: 10.1016/j.jmig.2014.09.008. Epub 2014 Nov 13.
PMID: 25265887
citation: Donnez O, Donnez J, Dolmans MM, Dethy A, Baeyens M, Mitchell J. Low Pain Score After Total Laparoscopic Hysterectomy and Same-Day Discharge Within Less Than 5 Hours: Results of a Prospective Observational Study. J Minim Invasive Gynecol. 2015 Nov-Dec;22(7):1293-9. doi: 10.1016/j.jmig.2015.06.021. Epub 2015 Jul 11.
PMID: 26169246
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responsible party type: Sponsor
mesh term: Pain, Postoperative
mesh term: Bupivacaine
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 