<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/NCT04428320</url>
  </required_header>
  <id_info>
    <org_study_id>19-124</org_study_id>
    <nct_id>NCT04428320</nct_id>
  </id_info>
  <brief_title>The Effect of Preemptive Levator Ani Injections on Pain After Pelvic Reconstructive Surgery</brief_title>
  <official_title>The Effect of Preemptive Levator Ani Injections on Pain After Pelvic Reconstructive Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Cooper Health System</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Cooper Health System</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients undergoing vaginal pelvic reconstructive surgery for pelvic organ prolapse (POP)&#xD;
      under general anesthesia will be randomized to receive bilateral trans-vaginal pelvic floor&#xD;
      muscle injections with bupivacaine or no injection (standard of care) as a part of their&#xD;
      surgical pain control&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients undergoing vaginal pelvic reconstructive surgery for pelvic organ prolapse (POP)&#xD;
      under general anesthesia will be randomized to receive:&#xD;
&#xD;
        1. Bilateral trans- vaginal pelvic floor levator ani muscle injections (trigger point&#xD;
           injections) with bupivacaine:&#xD;
&#xD;
           - 0.5% bupivacaine will be injected at several sites for a total of 5ml on each side of&#xD;
           the pelvic floor, with each injection site no more than 1 ml (Bupivacaine was chosen by&#xD;
           the study team because of it has a longer half life then other common local anesthetics.&#xD;
           We plan to use the same anesthetic and dosage to standardize the protocol between&#xD;
           patients. Other local anesthetics will not be used in addition to the bupivacaine&#xD;
           administered for research purposes. We will limit the amount of intravenous lidocaine to&#xD;
           less than 5mg/ kg).&#xD;
&#xD;
        2. Control- No additional treatment (standard of care).&#xD;
&#xD;
      The patient will be blinded to their randomization (single blind). The post-operative pain&#xD;
      regimen will be standardized when possible. Patients will receive a regimen of IV and oral&#xD;
      narcotics and Ketorolac per our routine post-operative protocol. On discharge from the&#xD;
      hospital, patients will be given prescriptions for a standard amount of oral narcotic, 20&#xD;
      tablets of oxycodone (150 morphine equivalents), and 30 tablets of 600mg ibuprofen.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 21, 2020</start_date>
  <completion_date type="Anticipated">May 21, 2022</completion_date>
  <primary_completion_date type="Anticipated">May 21, 2022</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>
    <intervention_model_description>Randomized Control Trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>VAS analog scale on post-op day #1</measure>
    <time_frame>postop day #1</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">140</enrollment>
  <condition>Pelvic Floor Prolapse</condition>
  <condition>Surgery</condition>
  <condition>Pain, Postoperative</condition>
  <arm_group>
    <arm_group_label>Bupivicaine pelvic floor muscle injection</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Five injections at pre-specified locations at pelvic floor muscle bilaterally after induction of general anesthesia for vaginal pelvic prolapse surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of care (no injection) preoperatively</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No injection - standard analgesia</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Pelvic floor injection</intervention_name>
    <description>Injection of 10 cc of bupivacaine</description>
    <arm_group_label>Bupivicaine pelvic floor muscle injection</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female&#xD;
&#xD;
          -  Able to read English and give informed consent&#xD;
&#xD;
          -  Undergoing VAGINAL pelvic reconstructive surgery for POP&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hypersensitivity or allergy to amide anesthetics&#xD;
&#xD;
          -  Documented chronic pain condition&#xD;
&#xD;
             o (back pain, pelvic pain, fibromyalgia, etc.)&#xD;
&#xD;
          -  Bleeding disorder&#xD;
&#xD;
          -  Connective tissue disorder&#xD;
&#xD;
          -  Neuromuscular disorder&#xD;
&#xD;
          -  Cardiac conduction abnormality or channelopathy&#xD;
&#xD;
          -  Hepatic Impairment&#xD;
&#xD;
          -  Renal Impairment&#xD;
&#xD;
          -  History of, or current, narcotic or alcohol dependence&#xD;
&#xD;
          -  History of pelvic radiation or gynecologic malignancy&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Pelvic organ prolapse surgery for female genitalia</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Lioudmila Lipetskaia, MD</last_name>
    <phone>610-462-608</phone>
    <email>lipetskaia-lioudmila@cooperhealth.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Devon Smith, MD</last_name>
    <email>smith-devon@cooperhealth.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Cooper Health University</name>
      <address>
        <city>Camden</city>
        <state>New Jersey</state>
        <zip>08105</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lioudmila Lipetskaia</last_name>
      <phone>610-462-1608</phone>
      <email>lipetskaia-lioudmila@cooperhealth.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 9, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>June 9, 2020</last_update_submitted>
  <last_update_submitted_qc>June 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prolapse</mesh_term>
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No sharing planned as of now</ipd_description>
  </patient_data>
  <!-- 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/NCT04428320
org study id: 19-124
nct id: NCT04428320
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Patients undergoing vaginal pelvic reconstructive surgery for pelvic organ prolapse (POP)
      under general anesthesia will be randomized to receive bilateral trans-vaginal pelvic floor
      muscle injections with bupivacaine or no injection (standard of care) as a part of their
      surgical pain control
Patients undergoing vaginal pelvic reconstructive surgery for pelvic organ prolapse (POP)
      under general anesthesia will be randomized to receive:

        1. Bilateral trans- vaginal pelvic floor levator ani muscle injections (trigger point
           injections) with bupivacaine:

           - 0.5% bupivacaine will be injected at several sites for a total of 5ml on each side of
           the pelvic floor, with each injection site no more than 1 ml (Bupivacaine was chosen by
           the study team because of it has a longer half life then other common local anesthetics.
           We plan to use the same anesthetic and dosage to standardize the protocol between
           patients. Other local anesthetics will not be used in addition to the bupivacaine
           administered for research purposes. We will limit the amount of intravenous lidocaine to
           less than 5mg/ kg).

        2. Control- No additional treatment (standard of care).

      The patient will be blinded to their randomization (single blind). The post-operative pain
      regimen will be standardized when possible. Patients will receive a regimen of IV and oral
      narcotics and Ketorolac per our routine post-operative protocol. On discharge from the
      hospital, patients will be given prescriptions for a standard amount of oral narcotic, 20
      tablets of oxycodone (150 morphine equivalents), and 30 tablets of 600mg ibuprofen.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized Control Trial
primary purpose: Treatment
masking: Single (Participant)
measure: VAS analog scale on post-op day #1
time frame: postop day #1
arm group label: Bupivicaine pelvic floor muscle injection
arm group type: Experimental
description: Five injections at pre-specified locations at pelvic floor muscle bilaterally after induction of general anesthesia for vaginal pelvic prolapse surgery
arm group label: Standard of care (no injection) preoperatively
arm group type: No Intervention
description: No injection - standard analgesia
intervention type: Procedure
intervention name: Pelvic floor injection
description: Injection of 10 cc of bupivacaine
arm group label: Bupivicaine pelvic floor muscle injection
criteria: 
gender: Female
gender based: Yes
gender description: Pelvic organ prolapse surgery for female genitalia
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Lioudmila Lipetskaia, MD
phone: 610-462-608
email: lipetskaia-lioudmila@cooperhealth.edu
last name: Devon Smith, MD
email: smith-devon@cooperhealth.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Prolapse
mesh term: Pain, Postoperative
sharing ipd: No
ipd description: No sharing planned as of now