<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/NCT02999724</url>
  </required_header>
  <id_info>
    <org_study_id>16-0262-A</org_study_id>
    <nct_id>NCT02999724</nct_id>
  </id_info>
  <brief_title>Gabapentin Reduces Opioid Use Postoperatively (&quot;GROUP Study&quot;)</brief_title>
  <acronym>GROUP</acronym>
  <official_title>Gabapentin Reduces Opioid Use Postoperatively (&quot;GROUP Study&quot;): A Randomized Control Trial in Women Undergoing Reconstructive Pelvic Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mount Sinai Hospital, Canada</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mount Sinai Hospital, Canada</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Gabapentin is a medication used primarily to treat seizures and pain. Studies have shown that&#xD;
      this medication can help reduce pain after surgery, including hysterectomy, where the uterus&#xD;
      or &quot;womb&quot; is removed. Opioids are the first choice for pain medication administered after&#xD;
      surgery, but carry significant side effects. Several studies have demonstrated that if&#xD;
      patients are given gabapentin before surgery, they require less opioids after surgery.&#xD;
      However, there have not been any studies examining gabapentin's effects on post-operative&#xD;
      pain in urogynecologic surgery, which treats pelvic organ prolapse and urinary incontinence.&#xD;
      Pelvic organ prolapse occurs when female pelvic floor supports have weakened and therefore&#xD;
      patients experience a &quot;bulge&quot; or &quot;pressure&quot; in the vagina. Patients with these conditions are&#xD;
      typically offered medical treatments, but some may require surgery, and this usually consists&#xD;
      of vaginal hysterectomy, pelvic floor repair, and a mid-urethral sling to treat any&#xD;
      concurrent urinary incontinence. Our study aims to look at the effect of gabapentin given to&#xD;
      patients undergoing urogynecologic surgery on their pain levels after surgery, including the&#xD;
      amount of opioid pain medication required. We hypothesize that the patients who receive&#xD;
      gabapentin before surgery will require significantly less opioids.&#xD;
&#xD;
      Over a six-month period, patients seen in Urogynecology clinics will be invited to&#xD;
      participate in the study. Women who are already on gabapentin for other reasons, have an&#xD;
      allergy to gabapentin, have a reason they cannot take gabapentin, or who cannot understand&#xD;
      spoken English will be excluded from the study. After providing informed consent, they will&#xD;
      be randomized to either receive gabapentin or a placebo pill. They will receive the standard&#xD;
      surgical care, including the usual anesthesia for surgery and routine pain medications&#xD;
      available after surgery. We will then compare the differences in opioid consumption in the&#xD;
      first 24 hours after surgery as well as the time from the end of surgery to leaving to the&#xD;
      recovery room and the length of recovery room stay between the gabapentin and placebo groups.&#xD;
      We will also analyze the differences in anxiety, drowsiness, pain, and nausea as rated by the&#xD;
      patients in each group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will be a randomized double blinded placebo controlled trial. All women presenting&#xD;
      to Mount Sinai Hospital eligible for surgery with pelvic organ prolapse symptoms requiring&#xD;
      hysterectomy with other pelvic reconstruction (repair of cystocele and/or rectocele, with or&#xD;
      without TVT) will be provided with a written informed consent to be randomized to either&#xD;
      receiving pre-operative gabapentin single dose or placebo 2 hours prior to surgery. The&#xD;
      single dose of gabapentin will be 600 mg for patients under 65 years old and 300 mg for those&#xD;
      65 years old and above. All patients will have pre-operative assessment according to the&#xD;
      usual routine that will include urogynecological history taking, physical examination,&#xD;
      urodynamic testing and blood work. Urodynamic testing will include measurement of the&#xD;
      post-void residual by urethral catheterization or bladder scan, uroflowmetry, a filling&#xD;
      cystometrogram and urethral pressure profilometry. Medication and placebo will be prepared by&#xD;
      the hospital pharmacy to look alike to blind staff and patients. Medication or placebo will&#xD;
      be given with other pre-anesthesia medications such as celecoxib and acetaminophen according&#xD;
      to usual protocol. Routine peri-operative surgical/anesthesia management will be unchanged&#xD;
      from the usual care. Post-operative pain score will be measured using a visual analogue scale&#xD;
      (VAS) from 1 to 10. Total Opioids use during the first 24 hours after surgery will be&#xD;
      calculated from patients' paper and electronic chart, and conversion will be made to morphine&#xD;
      equivalents.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">January 2018</completion_date>
  <primary_completion_date type="Anticipated">September 2017</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>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>opioid consumption postop</measure>
    <time_frame>24 hours</time_frame>
    <description>total opioid use 24 hours after surgery</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">44</enrollment>
  <condition>Pelvic Organ Prolapse</condition>
  <arm_group>
    <arm_group_label>gabapentin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>gabapentin 300-600 mg 1 hour preop</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>placebo capsule(s) 1 hour preop</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Gabapentin</intervention_name>
    <description>Gabapentin 300-600 mg 1 hour preop</description>
    <arm_group_label>gabapentin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>placebo</intervention_name>
    <description>placebo capsule(s) 1 hour preop</description>
    <arm_group_label>placebo</arm_group_label>
    <other_name>placebo capsule</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  women age 18 years and older&#xD;
&#xD;
          -  uterovaginal prolapse with or without stress urinary incontinence&#xD;
&#xD;
          -  booked for vaginal hysterectomy, anterior and/or posterior vaginal repair, with or&#xD;
             without TVT&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women already on gabapentin for other indications&#xD;
&#xD;
          -  Women with proven allergy or sensitivity to gabapentin&#xD;
&#xD;
          -  Women with a contraindication to gabapentin&#xD;
&#xD;
          -  Women unable to understand spoken English&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Danny Lovatsis, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sinai Health System</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Danny Lovatsis, MD</last_name>
    <phone>416-586-4566</phone>
    <email>danny.lovatsis@sinaihealthsystem.ca</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Adrienne Li, MD</last_name>
    <phone>416-586-4566</phone>
    <email>adrienne.lk.li@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Department of Obstetrics and Gynecology, Mount Sinai Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G1Z5</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Danny Lovatsis, MD MSc</last_name>
      <phone>4165864566</phone>
      <email>dlovatsis@mtsinai.on.ca</email>
    </contact>
    <contact_backup>
      <last_name>Adrienne Li, MD</last_name>
      <phone>416-586-4566</phone>
      <email>adrienne.lk.li@gmail.com</email>
    </contact_backup>
    <investigator>
      <last_name>Danny Lovatsis, MD MSc</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Adrienne Li, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>December 17, 2016</study_first_submitted>
  <study_first_submitted_qc>December 17, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 21, 2016</study_first_posted>
  <last_update_submitted>February 12, 2017</last_update_submitted>
  <last_update_submitted_qc>February 12, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">February 14, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mount Sinai Hospital, Canada</investigator_affiliation>
    <investigator_full_name>Danny Lovatsis</investigator_full_name>
    <investigator_title>Dr.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prolapse</mesh_term>
    <mesh_term>Pelvic Organ Prolapse</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gabapentin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT02999724
org study id: 16-0262-A
nct id: NCT02999724
lead sponsor: 
has dmc: No
Gabapentin is a medication used primarily to treat seizures and pain. Studies have shown that
      this medication can help reduce pain after surgery, including hysterectomy, where the uterus
      or "womb" is removed. Opioids are the first choice for pain medication administered after
      surgery, but carry significant side effects. Several studies have demonstrated that if
      patients are given gabapentin before surgery, they require less opioids after surgery.
      However, there have not been any studies examining gabapentin's effects on post-operative
      pain in urogynecologic surgery, which treats pelvic organ prolapse and urinary incontinence.
      Pelvic organ prolapse occurs when female pelvic floor supports have weakened and therefore
      patients experience a "bulge" or "pressure" in the vagina. Patients with these conditions are
      typically offered medical treatments, but some may require surgery, and this usually consists
      of vaginal hysterectomy, pelvic floor repair, and a mid-urethral sling to treat any
      concurrent urinary incontinence. Our study aims to look at the effect of gabapentin given to
      patients undergoing urogynecologic surgery on their pain levels after surgery, including the
      amount of opioid pain medication required. We hypothesize that the patients who receive
      gabapentin before surgery will require significantly less opioids.

      Over a six-month period, patients seen in Urogynecology clinics will be invited to
      participate in the study. Women who are already on gabapentin for other reasons, have an
      allergy to gabapentin, have a reason they cannot take gabapentin, or who cannot understand
      spoken English will be excluded from the study. After providing informed consent, they will
      be randomized to either receive gabapentin or a placebo pill. They will receive the standard
      surgical care, including the usual anesthesia for surgery and routine pain medications
      available after surgery. We will then compare the differences in opioid consumption in the
      first 24 hours after surgery as well as the time from the end of surgery to leaving to the
      recovery room and the length of recovery room stay between the gabapentin and placebo groups.
      We will also analyze the differences in anxiety, drowsiness, pain, and nausea as rated by the
      patients in each group.
This study will be a randomized double blinded placebo controlled trial. All women presenting
      to Mount Sinai Hospital eligible for surgery with pelvic organ prolapse symptoms requiring
      hysterectomy with other pelvic reconstruction (repair of cystocele and/or rectocele, with or
      without TVT) will be provided with a written informed consent to be randomized to either
      receiving pre-operative gabapentin single dose or placebo 2 hours prior to surgery. The
      single dose of gabapentin will be 600 mg for patients under 65 years old and 300 mg for those
      65 years old and above. All patients will have pre-operative assessment according to the
      usual routine that will include urogynecological history taking, physical examination,
      urodynamic testing and blood work. Urodynamic testing will include measurement of the
      post-void residual by urethral catheterization or bladder scan, uroflowmetry, a filling
      cystometrogram and urethral pressure profilometry. Medication and placebo will be prepared by
      the hospital pharmacy to look alike to blind staff and patients. Medication or placebo will
      be given with other pre-anesthesia medications such as celecoxib and acetaminophen according
      to usual protocol. Routine peri-operative surgical/anesthesia management will be unchanged
      from the usual care. Post-operative pain score will be measured using a visual analogue scale
      (VAS) from 1 to 10. Total Opioids use during the first 24 hours after surgery will be
      calculated from patients' paper and electronic chart, and conversion will be made to morphine
      equivalents.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: opioid consumption postop
time frame: 24 hours
description: total opioid use 24 hours after surgery
arm group label: gabapentin
arm group type: Experimental
description: gabapentin 300-600 mg 1 hour preop
arm group label: placebo
arm group type: Placebo Comparator
description: placebo capsule(s) 1 hour preop
intervention type: Drug
intervention name: Gabapentin
description: Gabapentin 300-600 mg 1 hour preop
arm group label: gabapentin
intervention type: Other
intervention name: placebo
description: placebo capsule(s) 1 hour preop
arm group label: placebo
other name: placebo capsule
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Danny Lovatsis, MD
role: Principal Investigator
affiliation: Sinai Health System
last name: Danny Lovatsis, MD
phone: 416-586-4566
email: danny.lovatsis@sinaihealthsystem.ca
last name: Adrienne Li, MD
phone: 416-586-4566
email: adrienne.lk.li@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Mount Sinai Hospital, Canada
investigator full name: Danny Lovatsis
investigator title: Dr.
mesh term: Prolapse
mesh term: Pelvic Organ Prolapse
mesh term: Gabapentin
sharing ipd: No