<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/NCT04491786</url>
  </required_header>
  <id_info>
    <org_study_id>GiaDinhPH</org_study_id>
    <nct_id>NCT04491786</nct_id>
  </id_info>
  <brief_title>The Efficacy of Postoperative Analgesia of Gabapentin Plus Nefopam in the Spinal Surgery</brief_title>
  <official_title>Department of Anaesthesiology</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gia Dinh People Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Gia Dinh People Hospital</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>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The acute pain after spinal surgery is serious. The most pain is during 24 hours after&#xD;
      surgery. The multimodal therapy is a method which is applied to treat the postoperative pain.&#xD;
&#xD;
      Morphine is main analgesic to treat postoperative pain. However, some the side-effects can&#xD;
      occur to patients and there are associate with dosage. So, some analgesics usually combinate&#xD;
      with morphine to postoperative analgesia, include gabapentin, celecoxib, ketamine, ...&#xD;
&#xD;
      Nefopam is a central analgesic. There are effect prevent hyperalgesia. The effect of the&#xD;
      combination of gabapentin with nefopam to postoperative analgesia in spinal surgery hasn't&#xD;
      been reported yet.&#xD;
&#xD;
      The gabapentin oral with 600 mg combine with continuously intravenous nefopam with 65&#xD;
      µg/kg/hour during 24 hours after spinal surgery whether to increase the effect of&#xD;
      postoperative analgesia.&#xD;
&#xD;
      The investigators hypothesized that the gabapentin oral with 600 mg combine with continuously&#xD;
      intravenous nefopam with 65 µg/kg/hour during 24 hours after spinal surgery can decrease 40%&#xD;
      of the consumption of morphine during 24 hours.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After enrolled, all participants will randomly assigned into the two groups. The intervention&#xD;
      group (GAPA-group) will treated preoperative oral 600 mg of gabapentin. After general&#xD;
      anesthesia, all participants of both groups will continuously transfused 65 µg/kg/hour of&#xD;
      nefopam during 24 hours. After surgery, all cases will treated analgesia with morphine-PCA (2&#xD;
      mg of singe dose, 5 minutes of lockout time, and 6 mg of one hour).&#xD;
&#xD;
      The efficacy of postoperative analgesia will evaluated with the consumption of morphine&#xD;
      during 24 hours.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2020</start_date>
  <completion_date type="Actual">May 31, 2021</completion_date>
  <primary_completion_date type="Actual">May 1, 2021</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>The intervention group will treated postoperative analgesia with 600 mg of gabapentin plus 65 mcg/kg/hour during 24 hours of nefopam</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Consumption of morphine</measure>
    <time_frame>Postoperative 24 hours</time_frame>
    <description>Concentration of morphine that participant use during postoperative 24 hours with PCA (mg)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Side-effect</measure>
    <time_frame>Postoperative 24 hours</time_frame>
    <description>The rate of side-effect induced gabapentin, nefopam, and morphine</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Spinal Fusion</condition>
  <arm_group>
    <arm_group_label>GAPA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will treated with preoperative 600 mg of gabapentin plus nefopam which will continuously transfused during intraoperative and postoperative 24 hours, and morphine-PCA during postoperative 24 hours</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-GAPA</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants will treated with nefopam which will continuously transfused during intraoperative and postoperative 24 hours, and morphine-PCA during postoperative 24 hours</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Gabapentin</intervention_name>
    <description>Gabapentin plus nefopam</description>
    <arm_group_label>GAPA</arm_group_label>
    <other_name>Nefopam</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age from 18 to 70.&#xD;
&#xD;
          -  Spinal selective surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Allergy one of drugs in study.&#xD;
&#xD;
          -  Neurological disorder.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Binh V. Huynh</last_name>
    <role>Study Chair</role>
    <affiliation>Nhan dan Gia Dinh Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Binh Huynh</name>
      <address>
        <city>Ho Chi Minh City</city>
        <state>Ho Chi Minh</state>
        <zip>70000</zip>
        <country>Vietnam</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Vietnam</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>July 26, 2020</study_first_submitted>
  <study_first_submitted_qc>July 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 29, 2020</study_first_posted>
  <last_update_submitted>June 4, 2021</last_update_submitted>
  <last_update_submitted_qc>June 4, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 7, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Gabapentin</keyword>
  <keyword>Nefopam</keyword>
  <keyword>Spinal surgery</keyword>
  <keyword>Postoperative analgesia</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gabapentin</mesh_term>
    <mesh_term>Nefopam</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/NCT04491786
org study id: GiaDinhPH
nct id: NCT04491786
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: Yes
The acute pain after spinal surgery is serious. The most pain is during 24 hours after
      surgery. The multimodal therapy is a method which is applied to treat the postoperative pain.

      Morphine is main analgesic to treat postoperative pain. However, some the side-effects can
      occur to patients and there are associate with dosage. So, some analgesics usually combinate
      with morphine to postoperative analgesia, include gabapentin, celecoxib, ketamine, ...

      Nefopam is a central analgesic. There are effect prevent hyperalgesia. The effect of the
      combination of gabapentin with nefopam to postoperative analgesia in spinal surgery hasn't
      been reported yet.

      The gabapentin oral with 600 mg combine with continuously intravenous nefopam with 65
      µg/kg/hour during 24 hours after spinal surgery whether to increase the effect of
      postoperative analgesia.

      The investigators hypothesized that the gabapentin oral with 600 mg combine with continuously
      intravenous nefopam with 65 µg/kg/hour during 24 hours after spinal surgery can decrease 40%
      of the consumption of morphine during 24 hours.
After enrolled, all participants will randomly assigned into the two groups. The intervention
      group (GAPA-group) will treated preoperative oral 600 mg of gabapentin. After general
      anesthesia, all participants of both groups will continuously transfused 65 µg/kg/hour of
      nefopam during 24 hours. After surgery, all cases will treated analgesia with morphine-PCA (2
      mg of singe dose, 5 minutes of lockout time, and 6 mg of one hour).

      The efficacy of postoperative analgesia will evaluated with the consumption of morphine
      during 24 hours.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The intervention group will treated postoperative analgesia with 600 mg of gabapentin plus 65 mcg/kg/hour during 24 hours of nefopam
primary purpose: Treatment
masking: None (Open Label)
measure: Consumption of morphine
time frame: Postoperative 24 hours
description: Concentration of morphine that participant use during postoperative 24 hours with PCA (mg)
measure: Side-effect
time frame: Postoperative 24 hours
description: The rate of side-effect induced gabapentin, nefopam, and morphine
arm group label: GAPA
arm group type: Experimental
description: Participants will treated with preoperative 600 mg of gabapentin plus nefopam which will continuously transfused during intraoperative and postoperative 24 hours, and morphine-PCA during postoperative 24 hours
arm group label: Non-GAPA
arm group type: No Intervention
description: Participants will treated with nefopam which will continuously transfused during intraoperative and postoperative 24 hours, and morphine-PCA during postoperative 24 hours
intervention type: Drug
intervention name: Gabapentin
description: Gabapentin plus nefopam
arm group label: GAPA
other name: Nefopam
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Binh V. Huynh
role: Study Chair
affiliation: Nhan dan Gia Dinh Hospital
facility: 
country: Vietnam
responsible party type: Sponsor
mesh term: Gabapentin
mesh term: Nefopam