<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/NCT03023501</url>
  </required_header>
  <id_info>
    <org_study_id>E-13-902</org_study_id>
    <nct_id>NCT03023501</nct_id>
  </id_info>
  <brief_title>Effect of Gabapentin on Postoperative Morphine Consumption After Sleeve Gastrectomy</brief_title>
  <official_title>The Effect of Gabapentin on Postoperataive Pain ,Morphine Sparing Effect and Preoperative Anxiety in Bariatric Surgical Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>King Saud University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>King Saud University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The evidence regarding effects of pain modulator like gabapentin on postoperative pain after&#xD;
      sleeve gastrctomy is sparse. Gabapentin has anti-hyperalgesic and postoperative&#xD;
      opioid-sparing properties.This study will highlight the effectiveness of preoperative use of&#xD;
      gabapentin for postoperative pain management in morbidly obese patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Research Problem: Laprocopic sleeve gastrectomy is the most common surgical procedure&#xD;
      performed for reducing weight in morbidly obese patients. Laparoscopic surgery is considered&#xD;
      to be less invasive than open surgery. The treatment of pain in obese patients is a&#xD;
      challenge. Administering opioids, can have an increasing effect of respiratory depression in&#xD;
      patients already at risk of sleep apnea. The evidence regarding effects of pain modulator&#xD;
      like gabapentin on postoperative pain after sleeve gastrctomy is sparse. Gabapentin has&#xD;
      anti-hyperalgesic and postoperative opioid-sparing properties. The analgesic effect of&#xD;
      gabapentin appears to be related to the surgical procedure undertaken, a more&#xD;
      procedure-specific evaluation is needed for different types of surgeries..&#xD;
&#xD;
      Research Significance: This study will highlight the effectiveness of preoperative use of&#xD;
      gabapentin for postoperative pain management in morbidly obese patients.&#xD;
&#xD;
      Research Objectives: To evaluate the effect of preoperative administration of gabapentin on&#xD;
      postoperative pain, postoperative morphine consumption and preoperative anxiety in patients&#xD;
      coming for laparoscopic sleeve gastrectomy.&#xD;
&#xD;
      Research Methodology:&#xD;
&#xD;
      Inclusion criteria: ASA I and II, Age 18-50 years, either sex, Planned Surgical procedure&#xD;
      laparoscopic sleeve garstectomy, BMI 30-45 . Exclusion criteria: Patients taking any&#xD;
      sedative, tranquillizers , history of sleep apnoea ,contraindications to gabapentin, Methods&#xD;
      Patients will be randomly assigned into two groups, Group-Control and , Group- Gabapentin of&#xD;
      25 each. Anesthesia and postoperative course will be standardized. VAS scale will be used for&#xD;
      assessment of preoperative anxiety and postoperative pain. Post operatively pain assessment&#xD;
      and morphine consumption will be performed for 24 hours in PACU and ward&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2014</start_date>
  <completion_date type="Actual">January 2017</completion_date>
  <primary_completion_date type="Actual">January 2017</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Post operative Morphine requirement</measure>
    <time_frame>At 2 hours in Post Anesthesia Care Unit</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Post operative pain</measure>
    <time_frame>At 2 hours in Post Anesthesia Care Unit</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Post operative Morphine requirement</measure>
    <time_frame>4 hourly in the ward for 24 hours</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Post operative pain</measure>
    <time_frame>4 hourly in the ward for 24 hours</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Preoperative anxiety</measure>
    <time_frame>30 minutes before surgery</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Postoperative Complications</condition>
  <arm_group>
    <arm_group_label>Gabapentin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Gabapentin 1200mg capsule was administered orally 2 hours before surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo capsule was prepared by hospital pharmacy and was administered orally 2 hours before surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Gabapentin</intervention_name>
    <arm_group_label>Gabapentin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo Oral Capsule</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA 1 and 2&#xD;
&#xD;
          -  BMI 35 - 45&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients taking any sedative or tranquillizers&#xD;
&#xD;
          -  Any contraindication to gabapentin.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 13, 2017</study_first_submitted>
  <study_first_submitted_qc>January 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 18, 2017</study_first_posted>
  <last_update_submitted>January 13, 2017</last_update_submitted>
  <last_update_submitted_qc>January 13, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 18, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>King Saud University</investigator_affiliation>
    <investigator_full_name>MUEEN ULLAH KHAN</investigator_full_name>
    <investigator_title>MUEEN ULLAH KHAN</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Postoperative Complications</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>Yes</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/NCT03023501
org study id: E-13-902
nct id: NCT03023501
lead sponsor: 
has dmc: Yes
The evidence regarding effects of pain modulator like gabapentin on postoperative pain after
      sleeve gastrctomy is sparse. Gabapentin has anti-hyperalgesic and postoperative
      opioid-sparing properties.This study will highlight the effectiveness of preoperative use of
      gabapentin for postoperative pain management in morbidly obese patients.
Research Problem: Laprocopic sleeve gastrectomy is the most common surgical procedure
      performed for reducing weight in morbidly obese patients. Laparoscopic surgery is considered
      to be less invasive than open surgery. The treatment of pain in obese patients is a
      challenge. Administering opioids, can have an increasing effect of respiratory depression in
      patients already at risk of sleep apnea. The evidence regarding effects of pain modulator
      like gabapentin on postoperative pain after sleeve gastrctomy is sparse. Gabapentin has
      anti-hyperalgesic and postoperative opioid-sparing properties. The analgesic effect of
      gabapentin appears to be related to the surgical procedure undertaken, a more
      procedure-specific evaluation is needed for different types of surgeries..

      Research Significance: This study will highlight the effectiveness of preoperative use of
      gabapentin for postoperative pain management in morbidly obese patients.

      Research Objectives: To evaluate the effect of preoperative administration of gabapentin on
      postoperative pain, postoperative morphine consumption and preoperative anxiety in patients
      coming for laparoscopic sleeve gastrectomy.

      Research Methodology:

      Inclusion criteria: ASA I and II, Age 18-50 years, either sex, Planned Surgical procedure
      laparoscopic sleeve garstectomy, BMI 30-45 . Exclusion criteria: Patients taking any
      sedative, tranquillizers , history of sleep apnoea ,contraindications to gabapentin, Methods
      Patients will be randomly assigned into two groups, Group-Control and , Group- Gabapentin of
      25 each. Anesthesia and postoperative course will be standardized. VAS scale will be used for
      assessment of preoperative anxiety and postoperative pain. Post operatively pain assessment
      and morphine consumption will be performed for 24 hours in PACU and ward
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Post operative Morphine requirement
time frame: At 2 hours in Post Anesthesia Care Unit
measure: Post operative pain
time frame: At 2 hours in Post Anesthesia Care Unit
measure: Post operative Morphine requirement
time frame: 4 hourly in the ward for 24 hours
measure: Post operative pain
time frame: 4 hourly in the ward for 24 hours
measure: Preoperative anxiety
time frame: 30 minutes before surgery
arm group label: Gabapentin
arm group type: Experimental
description: Gabapentin 1200mg capsule was administered orally 2 hours before surgery
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo capsule was prepared by hospital pharmacy and was administered orally 2 hours before surgery.
intervention type: Drug
intervention name: Gabapentin
arm group label: Gabapentin
intervention type: Drug
intervention name: Placebo Oral Capsule
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: King Saud University
investigator full name: MUEEN ULLAH KHAN
investigator title: MUEEN ULLAH KHAN
mesh term: Postoperative Complications
mesh term: Gabapentin
sharing ipd: Yes