<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/NCT01732666</url>
  </required_header>
  <id_info>
    <org_study_id>4-2011-0883</org_study_id>
    <nct_id>NCT01732666</nct_id>
  </id_info>
  <brief_title>Effect of Nefopam on Remifentanil Induced Postoperative Hyperalgesia</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yonsei University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yonsei University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Opioids has been reported to cause hyperalgesia. Opioid induced hyperalgesia (OIH) is defined&#xD;
      as paradoxically lowering the threshold of pain after the exposure of opioid. Remifentanil is&#xD;
      a short acting opioid that is commonly used during anesthesia and surgery. However, OIH was&#xD;
      reported to occur after surgery when large amount of remifentanil was administered. On the&#xD;
      other hand, nefopam is a centrally acting, non-opioid analgesic. Nefopam has been reported to&#xD;
      have analgesic and anti-hyperalgesic effect.&#xD;
&#xD;
      The investigators hypothesized that nefopam administration could prevent OIH or reduce the&#xD;
      severity of OIH. Therefore, the objective of the study is to find out the effect of nefopam&#xD;
      on remifentanil induced hyperalgesia in patients undergoing laparoscopic abdominal surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2012</start_date>
  <completion_date type="Actual">September 2012</completion_date>
  <primary_completion_date type="Actual">September 2012</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>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Hyperalgesic extent around surgical incision</measure>
    <time_frame>Postoperative 24 hr and 48 hr</time_frame>
    <description>The distance from the surgical incision to a point where patient does not feel pain when he gets stimuli with von Frey filament No.16 (122g/mm2).</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Patients Undergoing Laparoscopic Gastrectomy</condition>
  <arm_group>
    <arm_group_label>group L</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>receives 100 ml of 0.9% saline immediately after anesthesia induction and 0.05µg/kg/min of remifentanil during anesthesia.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>group H</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>100 ml of 0.9% saline immediately after anesthesia induction and 0.3 µg/kg/min of remifentanil during anesthesia.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>group N</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>20mg of nefopam mixed in 100 ml of 0.9% saline immediately after anesthesia induction and 0.3 µg/kg/min of remifentanil during anesthesia.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nefopam</intervention_name>
    <description>20 mg of Nefopam mixed in 100 ml of 0.9% saline IV immediately after induction of anesthesia.</description>
    <arm_group_label>group N</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>low dose remifentanil</intervention_name>
    <description>100 ml of 0.9% saline immediately after anesthesia induction and 0.05µg/kg/min of remifentanil during anesthesia.</description>
    <arm_group_label>group L</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>high dose remifentanil</intervention_name>
    <description>100 ml of 0.9% saline immediately after anesthesia induction and 0.3 µg/kg/min of remifentanil during anesthesia.</description>
    <arm_group_label>group H</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients undergoing laparoscopic gastrectomy&#xD;
&#xD;
          2. American Society of Anesthesiologists physical status I or II&#xD;
&#xD;
          3. aged from 20 to 65 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Past history of chronic pain&#xD;
&#xD;
          2. Drug or alcohol abuse&#xD;
&#xD;
          3. Psychotic disorder&#xD;
&#xD;
          4. Taking analgesics, anti-epileptics, and anti-depressants.&#xD;
&#xD;
          5. Taking opioids within 24 hrs&#xD;
&#xD;
          6. Renal disease&#xD;
&#xD;
          7. Neuromuscular disease.&#xD;
&#xD;
          8. Moderate to severe cardiovascular disease&#xD;
&#xD;
          9. Pregnant or breast-feeding&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Severance hospital</name>
      <address>
        <city>Seoul</city>
        <zip>120-752</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>February 2014</verification_date>
  <study_first_submitted>November 18, 2012</study_first_submitted>
  <study_first_submitted_qc>November 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 26, 2012</study_first_posted>
  <last_update_submitted>February 17, 2014</last_update_submitted>
  <last_update_submitted_qc>February 17, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 19, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Opioid-induced hyperalgesia (OIH)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperalgesia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Remifentanil</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/NCT01732666
org study id: 4-2011-0883
nct id: NCT01732666
lead sponsor: 
has dmc: No
Opioids has been reported to cause hyperalgesia. Opioid induced hyperalgesia (OIH) is defined
      as paradoxically lowering the threshold of pain after the exposure of opioid. Remifentanil is
      a short acting opioid that is commonly used during anesthesia and surgery. However, OIH was
      reported to occur after surgery when large amount of remifentanil was administered. On the
      other hand, nefopam is a centrally acting, non-opioid analgesic. Nefopam has been reported to
      have analgesic and anti-hyperalgesic effect.

      The investigators hypothesized that nefopam administration could prevent OIH or reduce the
      severity of OIH. Therefore, the objective of the study is to find out the effect of nefopam
      on remifentanil induced hyperalgesia in patients undergoing laparoscopic abdominal surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Double (Participant, Outcomes Assessor)
measure: Hyperalgesic extent around surgical incision
time frame: Postoperative 24 hr and 48 hr
description: The distance from the surgical incision to a point where patient does not feel pain when he gets stimuli with von Frey filament No.16 (122g/mm2).
arm group label: group L
arm group type: Placebo Comparator
description: receives 100 ml of 0.9% saline immediately after anesthesia induction and 0.05µg/kg/min of remifentanil during anesthesia.
arm group label: group H
arm group type: Placebo Comparator
description: 100 ml of 0.9% saline immediately after anesthesia induction and 0.3 µg/kg/min of remifentanil during anesthesia.
arm group label: group N
arm group type: Experimental
description: 20mg of nefopam mixed in 100 ml of 0.9% saline immediately after anesthesia induction and 0.3 µg/kg/min of remifentanil during anesthesia.
intervention type: Drug
intervention name: Nefopam
description: 20 mg of Nefopam mixed in 100 ml of 0.9% saline IV immediately after induction of anesthesia.
arm group label: group N
intervention type: Drug
intervention name: low dose remifentanil
description: 100 ml of 0.9% saline immediately after anesthesia induction and 0.05µg/kg/min of remifentanil during anesthesia.
arm group label: group L
intervention type: Drug
intervention name: high dose remifentanil
description: 100 ml of 0.9% saline immediately after anesthesia induction and 0.3 µg/kg/min of remifentanil during anesthesia.
arm group label: group H
criteria: 
gender: All
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Hyperalgesia
mesh term: Remifentanil
mesh term: Nefopam