<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/NCT02230735</url>
  </required_header>
  <id_info>
    <org_study_id>SouzaA</org_study_id>
    <nct_id>NCT02230735</nct_id>
  </id_info>
  <brief_title>Bupivacaine Injections Into Uterosacral Ligaments During Robotic Assisted Total Hysterectomies</brief_title>
  <official_title>Effectiveness of Bupivacaine With Epinephrine Injections Into the Uterosacral Ligaments for Post-operative Pain Control and the Use of Narcotic Pain Medication Following Robotic Assisted Total Hysterectomies</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Souza, Amanda, M.D.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Souza, Amanda, M.D.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Will patients that receive injections of Marcaine into the uterine nerve via the uterosacral&#xD;
      ligaments experience less pain postoperatively, need less narcotic pain medication and return&#xD;
      to activities of daily living sooner.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Gynecologists use paracervical blocks in the office for decreasing pain during office based&#xD;
      procedures. Paracervical blocks, in the office, work by injecting the cervix with local&#xD;
      anesthetic, typically lidocaine, at the area of the uterosacral ligaments. The uterosacral&#xD;
      ligaments contain the uterine nerve, which branches off of levels T12-L2. By injecting the&#xD;
      uterine nerve with the local anesthetic patients are better able to tolerate the procedure&#xD;
      and have decreased pain post procedure. In the office, paracervical blocks are performed&#xD;
      vaginally with injections at the 3 o'clock and 9 o'clock position of the cervix. The use of&#xD;
      paracervical blocks by Chudnoff et al reviewed the effectiveness of paracervical blocks in&#xD;
      office based procedures, however no one has evaluated the effectiveness of injecting the&#xD;
      uterosacral ligaments under direct visualization with the camera that is placed into the&#xD;
      abdomen during a robotic assisted gynecologic procedure. We propose that by injecting the&#xD;
      uterosacral ligaments and thus the uterine nerve during robotic assisted hysterectomies with&#xD;
      Marcaine (Bupivacaine 0.5% with epinephrine 1:200,000) we can offer patients superior pain&#xD;
      relief. The onset of action with Marcaine is rapid and anesthesia is long lasting. The&#xD;
      duration of anesthesia is significantly longer with Marcaine than any other commonly used&#xD;
      local anesthetic. It has also been noted that there is a period of analgesia that persists&#xD;
      after the return of sensation, during which time the need for strong analgesics is reduced.&#xD;
      By injecting Marcaine we hypothesize that patients will have decreased pain and need less&#xD;
      narcotic pain medication. This will allow the patient to return to normal activities of daily&#xD;
      living sooner.&#xD;
&#xD;
      This is a randomized controlled double blinded trial in which patients will be assigned to&#xD;
      receive saline (control group) or bupivacaine 0.5% with epinephrine 1:200,000 (treatment&#xD;
      group). The randomization will be performed through a computerized system in the pharmacy at&#xD;
      the pharmacy of the hospital where the study is occurring. The randomization will occur once&#xD;
      the patient has consented to the study. The treatment arm of the study will receive a total&#xD;
      injection of 14ml of bupivacaine with 7ml directed into the right uterosacral ligament and&#xD;
      7ml into the left uterosacral ligament. The control arm of the study will receive a total&#xD;
      injection of 14ml of normal saline with 7ml directed into the right uterosacral ligament and&#xD;
      7ml into the left uterosacral ligament. These injections will take place after the uterus and&#xD;
      cervix have been surgically removed and the vaginal cuff has been surgically closed.&#xD;
&#xD;
      The maximum dose of bupivacaine with epinephrine is 225mg. The total amount of bupivacaine&#xD;
      that we have chosen to inject is below the maximum allowable dosing and yet we believe will&#xD;
      be an adequate amount for providing pain relief.&#xD;
&#xD;
      Eligible patients will be consented for the study while in the preoperative holding area.&#xD;
      Once consented the patient will be given a medication diary form that they will take home.&#xD;
      The form asks the patient to fill in the name of pain medication that they were prescribed&#xD;
      and the dosage. They will also have an area for them to tally the number of pills they have&#xD;
      taken since being discharged from the hospital. If they take anything for pain other than&#xD;
      that prescribed by the physician who performed the surgery the patient will be taken out of&#xD;
      the study. The Wong-baker faces pain rating scale is included on the form which they will be&#xD;
      using to rate their pain during the telephone encounters.&#xD;
&#xD;
      The pharmacy will be notified once consent is obtained that the patient is participating in&#xD;
      the study. After which, the injectable solution will be sent to the OR labeled &quot;Study Drug.&quot;&#xD;
      The surgical team and the patient will be blinded to which arm they are assigned to. With the&#xD;
      use of a Bierman needle the solution will be injected into the uterine nerve as it courses&#xD;
      with the uterosacral ligaments on each side at the level of the vaginal cuff. If the&#xD;
      uterosacral ligaments cannot be easily identified, the patient will be excluded from the&#xD;
      study.&#xD;
&#xD;
      Follow up will take place via telephone encounters.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Study was never started.&#xD;
  </why_stopped>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">August 2014</completion_date>
  <primary_completion_date type="Actual">August 2014</primary_completion_date>
  <phase>N/A</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>Supportive Care</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain scores using wong-baker faces pain rating scale</measure>
    <time_frame>Post-operative day 1 or post-operative day 2 if they stay overnight following their surgery</time_frame>
    <description>Follow up will take place via telephone encounters on post-operative day number one, unless the patient is admitted overnight following the surgery which in that case the telephone encounters will take place on postoperative day two. The patient will be asked to rate their average pain score for that day using the Wong-Baker faces pain rating scale which will occur at the time of the phone encounter.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Type and amount of narcotic pain medication used to achieve pain relief</measure>
    <time_frame>Post-operative day number one and five. Post-opertive day two and six if they stay overnight following their surgery</time_frame>
    <description>The type and amount of narcotic pain medication used to achieve pain relief which will be documented using the medication diary given to patients prior to discharge home from the hospital.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain compared to a prior laparoscopic or robotic surgery</measure>
    <time_frame>Post-operative day one and five, post-operative day two and six if they stay overnight in the hospital following their surgery</time_frame>
    <description>Patient will be asked if they have ever had a laparoscopic or robotic surgery before and if they have how does their current pain with this surgery compare to their previous surgery. They will choose from the following answer choices: Worse, Better, No difference, Can not Recall.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ability to drive</measure>
    <time_frame>Post-operative day five, Postopertive day six if they stay overnight in the hospital following their surgery</time_frame>
    <description>Patient will be asked if they have been able to drive since their surgery. If they have been able to drive we will ask how many days after surgery were they able to start driving.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ability to perform household duties</measure>
    <time_frame>Post-operative day five, Posoperative day six if they stay overnight in the hospital following their surgery</time_frame>
    <description>On postoperative day five patient will be asked if they have been able to perform household duties. If their answer is yes they will then be asked how man days after their surgery were they able to start performing household duties</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ability to perform routine activities of daily living</measure>
    <time_frame>Post-opertive day five, Postopertive day six if they stay overnight in the hospital following their surgery</time_frame>
    <description>Patient will be asked if they have begun performing activities of daily living (i.e grooming, hygiene care, preparing meals). If patient says yes we will follow up asking the patient how many days after their surgery were they able to perform routine activities of daily living.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body Mass Index</measure>
    <time_frame>Obtained at time of admission to hospital</time_frame>
    <description>Patient will be weighed upon admission to the hospital and asked what their height is at which time a BMI will be calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary pain scores using wong-baker faces pain rating scale</measure>
    <time_frame>Post-operative day 5 or post-operative day 6 if they stay overnight following their surgery</time_frame>
    <description>The second follow up will take place via telephone encounters on post-operative day number five, unless the patient is admitted overnight following the surgery which in that case the telephone encounters will take place on postoperative days six. The patient will be asked to rate their average pain score for that day using the Wong-Baker faces pain rating scale which will occur at the time of the phone encounter.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>Bipivacaine 0.5% with epinephrine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Total of 14 ml of bupivacaine hydrochloride 0.5% with epinephrine 1:200,000, 7ml in right uterosacral ligament, 7ml in left uterosacral ligament</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Normal Saline</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Total of 14 ml of normal saline, 7ml into the right uterosacral ligament and 7ml into the left uterosacral ligament</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bipivacaine 0.5% with epinephrine</intervention_name>
    <description>Total of 14 ml of bupivacaine hydrochloride 0.5% with epinephrine 1:200,000, 7ml in right uterosacral ligament, 7ml in left uterosacral ligament</description>
    <arm_group_label>Bipivacaine 0.5% with epinephrine</arm_group_label>
    <other_name>Marcaine With Epinephrine 1:200,000</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Normal Saline</intervention_name>
    <description>(placebo for bupivacaine)</description>
    <arm_group_label>Normal Saline</arm_group_label>
    <other_name>0.7%NS</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing robotically assisted total hysterectomies with cystoscopy and with&#xD;
             or without procedures involving the adnexa (salpingectomies and&#xD;
             salpingo-oophorectomies)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing single incision procedures, those having supracervical&#xD;
             hysterectomies and additional procedures involving their pelvic floor (including&#xD;
             bladder neck suspension, anterior colophorraphy, posterior colophorraphy,&#xD;
             perinealplasty) and sacracolpopexy&#xD;
&#xD;
          -  Patients with allergies to bupivacaine and its derivatives&#xD;
&#xD;
          -  Patients taking monoamine oxidase inhibitors or tricyclic antidepressants&#xD;
&#xD;
          -  Patients with known clinically significant hepatic, gastrointestinal, renal,&#xD;
             haematological, urologic, neurological, respiratory, endocrine or cardiovascular&#xD;
             system abnormalities&#xD;
&#xD;
          -  Patients with abnormal ECG's and prolonged QT syndrome&#xD;
&#xD;
          -  Patients who are currently requiring narcotic pain medication or use narcotic pain&#xD;
             medications regularly (more than twice weekly)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Amanda M Souza, DO</last_name>
    <role>Principal Investigator</role>
    <affiliation>Souza, Amanda, M.D.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Botsford General Hospital</name>
      <address>
        <city>Farmington Hills</city>
        <state>Michigan</state>
        <zip>48336</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Chudnoff S, Einstein M, Levie M. Paracervical block efficacy in office hysteroscopic sterilization: a randomized controlled trial. Obstet Gynecol. 2010 Jan;115(1):26-34. doi: 10.1097/AOG.0b013e3181c51ace.</citation>
    <PMID>20027030</PMID>
  </reference>
  <verification_date>May 2016</verification_date>
  <study_first_submitted>August 12, 2014</study_first_submitted>
  <study_first_submitted_qc>August 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2014</study_first_posted>
  <last_update_submitted>May 4, 2016</last_update_submitted>
  <last_update_submitted_qc>May 4, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 5, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Robotic</keyword>
  <keyword>Hysterectomy</keyword>
  <keyword>Uterosacral</keyword>
  <keyword>Bupivacaine</keyword>
  <keyword>Robotic hysterectomy pain control</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Epinephrine</mesh_term>
    <mesh_term>Racepinephrine</mesh_term>
    <mesh_term>Epinephryl borate</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT02230735
org study id: SouzaA
nct id: NCT02230735
lead sponsor: 
has dmc: No
Will patients that receive injections of Marcaine into the uterine nerve via the uterosacral
      ligaments experience less pain postoperatively, need less narcotic pain medication and return
      to activities of daily living sooner.
Gynecologists use paracervical blocks in the office for decreasing pain during office based
      procedures. Paracervical blocks, in the office, work by injecting the cervix with local
      anesthetic, typically lidocaine, at the area of the uterosacral ligaments. The uterosacral
      ligaments contain the uterine nerve, which branches off of levels T12-L2. By injecting the
      uterine nerve with the local anesthetic patients are better able to tolerate the procedure
      and have decreased pain post procedure. In the office, paracervical blocks are performed
      vaginally with injections at the 3 o'clock and 9 o'clock position of the cervix. The use of
      paracervical blocks by Chudnoff et al reviewed the effectiveness of paracervical blocks in
      office based procedures, however no one has evaluated the effectiveness of injecting the
      uterosacral ligaments under direct visualization with the camera that is placed into the
      abdomen during a robotic assisted gynecologic procedure. We propose that by injecting the
      uterosacral ligaments and thus the uterine nerve during robotic assisted hysterectomies with
      Marcaine (Bupivacaine 0.5% with epinephrine 1:200,000) we can offer patients superior pain
      relief. The onset of action with Marcaine is rapid and anesthesia is long lasting. The
      duration of anesthesia is significantly longer with Marcaine than any other commonly used
      local anesthetic. It has also been noted that there is a period of analgesia that persists
      after the return of sensation, during which time the need for strong analgesics is reduced.
      By injecting Marcaine we hypothesize that patients will have decreased pain and need less
      narcotic pain medication. This will allow the patient to return to normal activities of daily
      living sooner.

      This is a randomized controlled double blinded trial in which patients will be assigned to
      receive saline (control group) or bupivacaine 0.5% with epinephrine 1:200,000 (treatment
      group). The randomization will be performed through a computerized system in the pharmacy at
      the pharmacy of the hospital where the study is occurring. The randomization will occur once
      the patient has consented to the study. The treatment arm of the study will receive a total
      injection of 14ml of bupivacaine with 7ml directed into the right uterosacral ligament and
      7ml into the left uterosacral ligament. The control arm of the study will receive a total
      injection of 14ml of normal saline with 7ml directed into the right uterosacral ligament and
      7ml into the left uterosacral ligament. These injections will take place after the uterus and
      cervix have been surgically removed and the vaginal cuff has been surgically closed.

      The maximum dose of bupivacaine with epinephrine is 225mg. The total amount of bupivacaine
      that we have chosen to inject is below the maximum allowable dosing and yet we believe will
      be an adequate amount for providing pain relief.

      Eligible patients will be consented for the study while in the preoperative holding area.
      Once consented the patient will be given a medication diary form that they will take home.
      The form asks the patient to fill in the name of pain medication that they were prescribed
      and the dosage. They will also have an area for them to tally the number of pills they have
      taken since being discharged from the hospital. If they take anything for pain other than
      that prescribed by the physician who performed the surgery the patient will be taken out of
      the study. The Wong-baker faces pain rating scale is included on the form which they will be
      using to rate their pain during the telephone encounters.

      The pharmacy will be notified once consent is obtained that the patient is participating in
      the study. After which, the injectable solution will be sent to the OR labeled "Study Drug."
      The surgical team and the patient will be blinded to which arm they are assigned to. With the
      use of a Bierman needle the solution will be injected into the uterine nerve as it courses
      with the uterosacral ligaments on each side at the level of the vaginal cuff. If the
      uterosacral ligaments cannot be easily identified, the patient will be excluded from the
      study.

      Follow up will take place via telephone encounters.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Double (Participant, Investigator)
measure: Pain scores using wong-baker faces pain rating scale
time frame: Post-operative day 1 or post-operative day 2 if they stay overnight following their surgery
description: Follow up will take place via telephone encounters on post-operative day number one, unless the patient is admitted overnight following the surgery which in that case the telephone encounters will take place on postoperative day two. The patient will be asked to rate their average pain score for that day using the Wong-Baker faces pain rating scale which will occur at the time of the phone encounter.
measure: Type and amount of narcotic pain medication used to achieve pain relief
time frame: Post-operative day number one and five. Post-opertive day two and six if they stay overnight following their surgery
description: The type and amount of narcotic pain medication used to achieve pain relief which will be documented using the medication diary given to patients prior to discharge home from the hospital.
measure: Pain compared to a prior laparoscopic or robotic surgery
time frame: Post-operative day one and five, post-operative day two and six if they stay overnight in the hospital following their surgery
description: Patient will be asked if they have ever had a laparoscopic or robotic surgery before and if they have how does their current pain with this surgery compare to their previous surgery. They will choose from the following answer choices: Worse, Better, No difference, Can not Recall.
measure: Ability to drive
time frame: Post-operative day five, Postopertive day six if they stay overnight in the hospital following their surgery
description: Patient will be asked if they have been able to drive since their surgery. If they have been able to drive we will ask how many days after surgery were they able to start driving.
measure: Ability to perform household duties
time frame: Post-operative day five, Posoperative day six if they stay overnight in the hospital following their surgery
description: On postoperative day five patient will be asked if they have been able to perform household duties. If their answer is yes they will then be asked how man days after their surgery were they able to start performing household duties
measure: Ability to perform routine activities of daily living
time frame: Post-opertive day five, Postopertive day six if they stay overnight in the hospital following their surgery
description: Patient will be asked if they have begun performing activities of daily living (i.e grooming, hygiene care, preparing meals). If patient says yes we will follow up asking the patient how many days after their surgery were they able to perform routine activities of daily living.
measure: Body Mass Index
time frame: Obtained at time of admission to hospital
description: Patient will be weighed upon admission to the hospital and asked what their height is at which time a BMI will be calculated.
measure: Secondary pain scores using wong-baker faces pain rating scale
time frame: Post-operative day 5 or post-operative day 6 if they stay overnight following their surgery
description: The second follow up will take place via telephone encounters on post-operative day number five, unless the patient is admitted overnight following the surgery which in that case the telephone encounters will take place on postoperative days six. The patient will be asked to rate their average pain score for that day using the Wong-Baker faces pain rating scale which will occur at the time of the phone encounter.
arm group label: Bipivacaine 0.5% with epinephrine
arm group type: Experimental
description: Total of 14 ml of bupivacaine hydrochloride 0.5% with epinephrine 1:200,000, 7ml in right uterosacral ligament, 7ml in left uterosacral ligament
arm group label: Normal Saline
arm group type: Placebo Comparator
description: Total of 14 ml of normal saline, 7ml into the right uterosacral ligament and 7ml into the left uterosacral ligament
intervention type: Drug
intervention name: Bipivacaine 0.5% with epinephrine
description: Total of 14 ml of bupivacaine hydrochloride 0.5% with epinephrine 1:200,000, 7ml in right uterosacral ligament, 7ml in left uterosacral ligament
arm group label: Bipivacaine 0.5% with epinephrine
other name: Marcaine With Epinephrine 1:200,000
intervention type: Drug
intervention name: Normal Saline
description: (placebo for bupivacaine)
arm group label: Normal Saline
other name: 0.7%NS
criteria: 
gender: Female
minimum age: 21 Years
maximum age: 65 Years
healthy volunteers: No
last name: Amanda M Souza, DO
role: Principal Investigator
affiliation: Souza, Amanda, M.D.
facility: 
country: United States
citation: Chudnoff S, Einstein M, Levie M. Paracervical block efficacy in office hysteroscopic sterilization: a randomized controlled trial. Obstet Gynecol. 2010 Jan;115(1):26-34. doi: 10.1097/AOG.0b013e3181c51ace.
PMID: 20027030
responsible party type: Sponsor
mesh term: Epinephrine
mesh term: Racepinephrine
mesh term: Epinephryl borate