<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/NCT04434430</url>
  </required_header>
  <id_info>
    <org_study_id>IndonesiaUAnes 054</org_study_id>
    <nct_id>NCT04434430</nct_id>
  </id_info>
  <brief_title>Preemptive Oral Gabapentin 600 mg in Reducing Morphine Requirement After Non Obstetric Lower Abdominal Surgery</brief_title>
  <official_title>Effectiveness of Preemptive Oral Gabapentin 600 mg on Morphine Requirement After Non Obstetric Lower Abdominal Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Indonesia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Indonesia University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This study aimed to get the information about the effectiveness of preemptive oral gabapentin&#xD;
      600 mg in reducing morphine requirement after non obstetric lower abdominal surgery&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Seventy-two subjects were given informed consent before enrolling the study and randomized&#xD;
      into two groups; gabapentin and placebo. Two hours before the incision, patients were given&#xD;
      preemptive analgesia, either gabapentin or placebo. Non-invasive blood pressure monitor,&#xD;
      electrocardiogram (ECG), and pulse oxymetry were set on the subjects in the operating room.&#xD;
      General anesthesia induction was done by fentanyl 2 mcg/kg and propofol 2 mg/kg. Endotracheal&#xD;
      tube (ETT) intubation was facilitated with atracurium 0.5 mg/kg as muscle relaxant.&#xD;
      Maintenance was done by sevoflurane, oxygen, and compressed air. After surgery, patients were&#xD;
      extubated until fully conscious. Patients will be transported to recovery room&#xD;
      postoperatively. Besides paracetamol as the postoperative analgesia, we also attached patient&#xD;
      controlled analgesia (PCA) system to patients' intravenous line using continuous ambulatory&#xD;
      delivery device (CADD) contained morphine 1 mg/ml with settings 1 mg per requirement,&#xD;
      interval limit within 5 minutes, maximum dose 6 mg/hour intravenously. Cumulative morphine&#xD;
      requirement, mean visual analogue scale, and time interval after surgery to the first&#xD;
      administration of morphine will be assessed in this study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 11, 2019</start_date>
  <completion_date type="Actual">February 29, 2020</completion_date>
  <primary_completion_date type="Actual">February 29, 2020</primary_completion_date>
  <phase>Phase 1/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>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cumulative morphine requirement within 24 hours after non obstetric lower abdominal surgery</measure>
    <time_frame>24 hours after surgery</time_frame>
    <description>Measured by total consumption of morphine on patient controlled analgesia machine</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain within 24 hours after non obstetric lower abdominal surgerysurgery: visual analogue scale</measure>
    <time_frame>24 hours after surgery</time_frame>
    <description>Measured by visual analogue scale The visual analogue scale is a measurement to assess the severity of pain. In this context, the patients will be assessed by letting them point the score on a device based on their pain experiences.&#xD;
The minimum value is 0 and the maximum is 10. The higher the score, the more severe the pain is.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain within 2 hours after non obstetric lower abdominal surgerysurgery: visual analogue scale</measure>
    <time_frame>2 hours after surgery</time_frame>
    <description>Measured by visual analogue scale The visual analogue scale is a measurement to assess the severity of pain. In this context, the patients will be assessed by letting them point the score on a device based on their pain experiences.&#xD;
The minimum value is 0 and the maximum is 10. The higher the score, the more severe the pain is.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain within 6 hours after non obstetric lower abdominal surgerysurgery: visual analogue scale</measure>
    <time_frame>6 hours after surgery</time_frame>
    <description>Measured by visual analogue scale The visual analogue scale is a measurement to assess the severity of pain. In this context, the patients will be assessed by letting them point the score on a device based on their pain experiences.&#xD;
The minimum value is 0 and the maximum is 10. The higher the score, the more severe the pain is.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain within 12 hours after non obstetric lower abdominal surgerysurgery: visual analogue scale</measure>
    <time_frame>12 hours after surgery</time_frame>
    <description>Measured by visual analogue scale The visual analogue scale is a measurement to assess the severity of pain. In this context, the patients will be assessed by letting them point the score on a device based on their pain experiences.&#xD;
The minimum value is 0 and the maximum is 10. The higher the score, the more severe the pain is.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative morphine requirement within 2 hours after non obstetric lower abdominal surgery</measure>
    <time_frame>2 hours after surgery</time_frame>
    <description>Measured by total consumption of morphine on patient controlled analgesia machine</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative morphine requirement within 6 hours after non obstetric lower abdominal surgery</measure>
    <time_frame>6 hours after surgery</time_frame>
    <description>Measured by total consumption of morphine on patient controlled analgesia machine</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative morphine requirement within 12 hours after non obstetric lower abdominal surgery</measure>
    <time_frame>12 hours after surgery</time_frame>
    <description>Measured by total consumption of morphine on patient controlled analgesia machine</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">72</enrollment>
  <condition>Non-obstetric Lower Abdominal Surgery</condition>
  <arm_group>
    <arm_group_label>Gabapentin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patient will receive preemptive oral gabapentin 600 mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patient will receive oral placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Gabapentin</intervention_name>
    <description>Oral Gabapentin 600 mg</description>
    <arm_group_label>Gabapentin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Oral NaCl 500 mg</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Male or female&#xD;
&#xD;
          -  Age: 18-65 years old&#xD;
&#xD;
          -  Weigh in range around 20% of the ideal body weight&#xD;
&#xD;
          -  Physical status ASA I-II&#xD;
&#xD;
          -  Scheduled for elective non-obstetric lower abdominal surgery with general anesthesia&#xD;
&#xD;
          -  Duration of surgery less than 4 hours&#xD;
&#xD;
          -  Patients who agreed to participate in this study and sign informed consent&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Patients who have history of allergy or hypersensitivity to gabapentin, paracetamol,&#xD;
             morphine, or the other opioids&#xD;
&#xD;
          -  Patients who consumed analgesia and NSAID less than 12 hours before surgery&#xD;
&#xD;
          -  Patients who experienced physical trauma less than 4 days before surgery&#xD;
&#xD;
          -  Patients who have contraindications to gabapentin, morphine, and paracetamol&#xD;
&#xD;
          -  Patients who were treated with neuraxial block or peripheral nerve block before and&#xD;
             during surgery&#xD;
&#xD;
          -  Patients who have history of diabetes, severe live or renal disease&#xD;
&#xD;
          -  Patients who were treated with antihypertension, sedatives, hypnotics,&#xD;
             antidepressants, and the other drugs that have effects on nervous system&#xD;
&#xD;
          -  Patients who have psychiatric disorders&#xD;
&#xD;
          -  Patients who consumed gabapentin before perioperative period&#xD;
&#xD;
          -  Pregnant or breastfeeding patients&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Cipto Mangunkusumo Cental National Hospital</name>
      <address>
        <city>Jakarta</city>
        <state>DKI Jakarta</state>
        <zip>10430</zip>
        <country>Indonesia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Indonesia</country>
  </location_countries>
  <results_reference>
    <citation>Weiser TG, Regenbogen SE, Thompson KD, Haynes AB, Lipsitz SR, Berry WR, Gawande AA. An estimation of the global volume of surgery: a modelling strategy based on available data. Lancet. 2008 Jul 12;372(9633):139-144. doi: 10.1016/S0140-6736(08)60878-8. Epub 2008 Jun 24.</citation>
    <PMID>18582931</PMID>
  </results_reference>
  <results_reference>
    <citation>Bruce J, Quinlan J. Chronic Post Surgical Pain. Rev Pain. 2011 Sep;5(3):23-9. doi: 10.1177/204946371100500306.</citation>
    <PMID>26526062</PMID>
  </results_reference>
  <results_reference>
    <citation>Ip HY, Abrishami A, Peng PW, Wong J, Chung F. Predictors of postoperative pain and analgesic consumption: a qualitative systematic review. Anesthesiology. 2009 Sep;111(3):657-77. doi: 10.1097/ALN.0b013e3181aae87a.</citation>
    <PMID>19672167</PMID>
  </results_reference>
  <results_reference>
    <citation>Shavit Y, Fridel K, Beilin B. Postoperative pain management and proinflammatory cytokines: animal and human studies. J Neuroimmune Pharmacol. 2006 Dec;1(4):443-51. doi: 10.1007/s11481-006-9043-1. Epub 2006 Sep 29.</citation>
    <PMID>18040817</PMID>
  </results_reference>
  <results_reference>
    <citation>Beilin B, Shavit Y, Trabekin E, Mordashev B, Mayburd E, Zeidel A, Bessler H. The effects of postoperative pain management on immune response to surgery. Anesth Analg. 2003 Sep;97(3):822-827. doi: 10.1213/01.ANE.0000078586.82810.3B.</citation>
    <PMID>12933409</PMID>
  </results_reference>
  <results_reference>
    <citation>Lee BH, Park JO, Suk KS, Kim TH, Lee HM, Park MS, Lee SH, Park S, Lee JY, Ko SK, Moon SH. Pre-emptive and multi-modal perioperative pain management may improve quality of life in patients undergoing spinal surgery. Pain Physician. 2013 May-Jun;16(3):E217-26.</citation>
    <PMID>23703420</PMID>
  </results_reference>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>May 29, 2020</study_first_submitted>
  <study_first_submitted_qc>June 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>September 5, 2021</last_update_submitted>
  <last_update_submitted_qc>September 5, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Indonesia University</investigator_affiliation>
    <investigator_full_name>Andi Ade Wijaya Ramlan</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>preemptive analgesia</keyword>
  <keyword>gabapentin</keyword>
  <keyword>morphine</keyword>
  <keyword>lower abdominal surgery</keyword>
  <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/NCT04434430
org study id: IndonesiaUAnes 054
nct id: NCT04434430
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study aimed to get the information about the effectiveness of preemptive oral gabapentin
      600 mg in reducing morphine requirement after non obstetric lower abdominal surgery
Seventy-two subjects were given informed consent before enrolling the study and randomized
      into two groups; gabapentin and placebo. Two hours before the incision, patients were given
      preemptive analgesia, either gabapentin or placebo. Non-invasive blood pressure monitor,
      electrocardiogram (ECG), and pulse oxymetry were set on the subjects in the operating room.
      General anesthesia induction was done by fentanyl 2 mcg/kg and propofol 2 mg/kg. Endotracheal
      tube (ETT) intubation was facilitated with atracurium 0.5 mg/kg as muscle relaxant.
      Maintenance was done by sevoflurane, oxygen, and compressed air. After surgery, patients were
      extubated until fully conscious. Patients will be transported to recovery room
      postoperatively. Besides paracetamol as the postoperative analgesia, we also attached patient
      controlled analgesia (PCA) system to patients' intravenous line using continuous ambulatory
      delivery device (CADD) contained morphine 1 mg/ml with settings 1 mg per requirement,
      interval limit within 5 minutes, maximum dose 6 mg/hour intravenously. Cumulative morphine
      requirement, mean visual analogue scale, and time interval after surgery to the first
      administration of morphine will be assessed in this study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Cumulative morphine requirement within 24 hours after non obstetric lower abdominal surgery
time frame: 24 hours after surgery
description: Measured by total consumption of morphine on patient controlled analgesia machine
measure: Pain within 24 hours after non obstetric lower abdominal surgerysurgery: visual analogue scale
time frame: 24 hours after surgery
description: Measured by visual analogue scale The visual analogue scale is a measurement to assess the severity of pain. In this context, the patients will be assessed by letting them point the score on a device based on their pain experiences.
The minimum value is 0 and the maximum is 10. The higher the score, the more severe the pain is.
measure: Pain within 2 hours after non obstetric lower abdominal surgerysurgery: visual analogue scale
time frame: 2 hours after surgery
description: Measured by visual analogue scale The visual analogue scale is a measurement to assess the severity of pain. In this context, the patients will be assessed by letting them point the score on a device based on their pain experiences.
The minimum value is 0 and the maximum is 10. The higher the score, the more severe the pain is.
measure: Pain within 6 hours after non obstetric lower abdominal surgerysurgery: visual analogue scale
time frame: 6 hours after surgery
description: Measured by visual analogue scale The visual analogue scale is a measurement to assess the severity of pain. In this context, the patients will be assessed by letting them point the score on a device based on their pain experiences.
The minimum value is 0 and the maximum is 10. The higher the score, the more severe the pain is.
measure: Pain within 12 hours after non obstetric lower abdominal surgerysurgery: visual analogue scale
time frame: 12 hours after surgery
description: Measured by visual analogue scale The visual analogue scale is a measurement to assess the severity of pain. In this context, the patients will be assessed by letting them point the score on a device based on their pain experiences.
The minimum value is 0 and the maximum is 10. The higher the score, the more severe the pain is.
measure: Cumulative morphine requirement within 2 hours after non obstetric lower abdominal surgery
time frame: 2 hours after surgery
description: Measured by total consumption of morphine on patient controlled analgesia machine
measure: Cumulative morphine requirement within 6 hours after non obstetric lower abdominal surgery
time frame: 6 hours after surgery
description: Measured by total consumption of morphine on patient controlled analgesia machine
measure: Cumulative morphine requirement within 12 hours after non obstetric lower abdominal surgery
time frame: 12 hours after surgery
description: Measured by total consumption of morphine on patient controlled analgesia machine
arm group label: Gabapentin
arm group type: Active Comparator
description: Patient will receive preemptive oral gabapentin 600 mg
arm group label: Placebo
arm group type: Placebo Comparator
description: Patient will receive oral placebo
intervention type: Drug
intervention name: Gabapentin
description: Oral Gabapentin 600 mg
arm group label: Gabapentin
intervention type: Other
intervention name: Placebo
description: Oral NaCl 500 mg
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: Indonesia
citation: Weiser TG, Regenbogen SE, Thompson KD, Haynes AB, Lipsitz SR, Berry WR, Gawande AA. An estimation of the global volume of surgery: a modelling strategy based on available data. Lancet. 2008 Jul 12;372(9633):139-144. doi: 10.1016/S0140-6736(08)60878-8. Epub 2008 Jun 24.
PMID: 18582931
citation: Bruce J, Quinlan J. Chronic Post Surgical Pain. Rev Pain. 2011 Sep;5(3):23-9. doi: 10.1177/204946371100500306.
PMID: 26526062
citation: Ip HY, Abrishami A, Peng PW, Wong J, Chung F. Predictors of postoperative pain and analgesic consumption: a qualitative systematic review. Anesthesiology. 2009 Sep;111(3):657-77. doi: 10.1097/ALN.0b013e3181aae87a.
PMID: 19672167
citation: Shavit Y, Fridel K, Beilin B. Postoperative pain management and proinflammatory cytokines: animal and human studies. J Neuroimmune Pharmacol. 2006 Dec;1(4):443-51. doi: 10.1007/s11481-006-9043-1. Epub 2006 Sep 29.
PMID: 18040817
citation: Beilin B, Shavit Y, Trabekin E, Mordashev B, Mayburd E, Zeidel A, Bessler H. The effects of postoperative pain management on immune response to surgery. Anesth Analg. 2003 Sep;97(3):822-827. doi: 10.1213/01.ANE.0000078586.82810.3B.
PMID: 12933409
citation: Lee BH, Park JO, Suk KS, Kim TH, Lee HM, Park MS, Lee SH, Park S, Lee JY, Ko SK, Moon SH. Pre-emptive and multi-modal perioperative pain management may improve quality of life in patients undergoing spinal surgery. Pain Physician. 2013 May-Jun;16(3):E217-26.
PMID: 23703420
responsible party type: Principal Investigator
investigator affiliation: Indonesia University
investigator full name: Andi Ade Wijaya Ramlan
investigator title: Principal Investigator
mesh term: Gabapentin
sharing ipd: No