<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/NCT04450355</url>
  </required_header>
  <id_info>
    <org_study_id>2001-036-1092</org_study_id>
    <nct_id>NCT04450355</nct_id>
  </id_info>
  <brief_title>Effects of Continuous Infusion of Intravenous Nefopam on Postoperative Pain and Opioid Consumption After VATS</brief_title>
  <official_title>Effects of Continuous Infusion of Intravenous Nefopam on Postoperative Pain and Opioid Consumption After Video Assisted Thoracic Surgery: A Double Blind Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Pharmbio Korea</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Seoul National University Hospital</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 prospective, randomized, double-blinded study is designed to evaluate the postoperative&#xD;
      analgesic effect of the continuous infusion of intravenous nefopam in patients undergoing&#xD;
      video-assisted thoracic surgery (VATS). We hypothesize that the continuous infusion of&#xD;
      intravenous nefopam can significantly reduce postoperative opioid consumption and pain&#xD;
      severity in patients with VATS.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Adult patients undergoing elective unilateral VATS segmentectomy or lobectomy are randomly&#xD;
      allocated to receive continuous nefopam infusion (n=45) or not (n=45), in addition to a&#xD;
      standard postoperative analgesic regimen comprising of IV fentanyl-based patient-controlled&#xD;
      analgesia (PCA). At the end of induction, the nefopam group will receive intravenous nefopam&#xD;
      20mg mixed with 50ml of normal saline, and at the end of surgery this group will receive&#xD;
      intravenous nefopam 60mg mixed with 50ml of normal saline at a rate of 2ml/hr. The control&#xD;
      group will receive intravenous normal saline 50ml at the end of induction and receive&#xD;
      intravenous normal saline 50ml at a rate of 2ml/hr.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 30, 2020</start_date>
  <completion_date type="Actual">November 10, 2021</completion_date>
  <primary_completion_date type="Actual">August 9, 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>A prospective randomized double-blinded study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>Outcomes assessor not involved in this study will investigate the outcomes. The patient will be not informed of the infusion of nefopam by not attaching an identifiable label so that it cannot be distinguished from normal saline.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Total fentanyl consumption during 24 hours</measure>
    <time_frame>postoperative 24 hours</time_frame>
    <description>postoperative fentanyl consumption (mcg) via IV patient controlled analgesia</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total fentanyl consumption</measure>
    <time_frame>postoperative 48 hours</time_frame>
    <description>postoperative fentanyl consumption (mcg) via IV patient controlled analgesia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative pain score</measure>
    <time_frame>postoperative 24, 48 hours</time_frame>
    <description>11-pointed NRS pain score at resting/coughing/movement NRS (0-10): 0, &quot;no pain&quot;; 10, &quot;worst pain imaginable&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative nausea and vomiting</measure>
    <time_frame>postoperative 24, 48 hours</time_frame>
    <description>Incidence of postoperative nausea and vomiting (%)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>chronic postsurgical pain</measure>
    <time_frame>3-months after surgery</time_frame>
    <description>Incidence of chronic postsurgical pain (NRS ≥ 3) (%)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Postoperative Pain</condition>
  <arm_group>
    <arm_group_label>Nefopam group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>At the end of induction, the nefopam group will receive intravenous nefopam 20mg mixed with 50ml of normal saline, and at the end of surgery, this group will receive intravenous nefopam 60mg mixed with 50ml of normal saline at a rate of 2ml/hr.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The control group will receive intravenous normal saline 50ml at the end of induction and receive intravenous normal saline 50ml at a rate of 2ml/hr at the end of surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nefopam 80mg/day</intervention_name>
    <description>continuous nefopam infusion</description>
    <arm_group_label>Nefopam group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Normal saline</intervention_name>
    <description>continuous normal saline infusion</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients scheduled to undergo elective unilateral VATS segmentectomy or lobectomy&#xD;
             under general anesthesia&#xD;
&#xD;
          -  American Society of Anesthesiologists (ASA) physical classification I-II&#xD;
&#xD;
          -  Consent to IV-patient controlled analgesia use&#xD;
&#xD;
          -  Willingness and ability to sign an informed consent document&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Do not understand our study&#xD;
&#xD;
          -  Allergies to anesthetic or analgesic medications&#xD;
&#xD;
          -  Continuous local anesthetics infiltration for postoperative pain control&#xD;
&#xD;
          -  Patients who receive mechanical ventilation more than 2 hours after surgery&#xD;
&#xD;
          -  Pregnancy/Breast feeder&#xD;
&#xD;
          -  Medical or psychological disease that can affect the treatment response&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>KS013</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <reference>
    <citation>Tirault M, Derrode N, Clevenot D, Rolland D, Fletcher D, Debaene B. The effect of nefopam on morphine overconsumption induced by large-dose remifentanil during propofol anesthesia for major abdominal surgery. Anesth Analg. 2006 Jan;102(1):110-7. doi: 10.1213/01.ANE.0000181103.07170.15.</citation>
    <PMID>16368814</PMID>
  </reference>
  <reference>
    <citation>Du Manoir B, Aubrun F, Langlois M, Le Guern ME, Alquier C, Chauvin M, Fletcher D. Randomized prospective study of the analgesic effect of nefopam after orthopaedic surgery. Br J Anaesth. 2003 Dec;91(6):836-41. doi: 10.1093/bja/aeg264.</citation>
    <PMID>14633755</PMID>
  </reference>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>June 24, 2020</study_first_submitted>
  <study_first_submitted_qc>June 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 29, 2020</study_first_posted>
  <last_update_submitted>May 4, 2022</last_update_submitted>
  <last_update_submitted_qc>May 4, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Hojin Lee, MD</investigator_full_name>
    <investigator_title>Clinical assistant professor</investigator_title>
  </responsible_party>
  <keyword>Postoperative Pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nefopam</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/NCT04450355
org study id: 2001-036-1092
nct id: NCT04450355
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This prospective, randomized, double-blinded study is designed to evaluate the postoperative
      analgesic effect of the continuous infusion of intravenous nefopam in patients undergoing
      video-assisted thoracic surgery (VATS). We hypothesize that the continuous infusion of
      intravenous nefopam can significantly reduce postoperative opioid consumption and pain
      severity in patients with VATS.
Adult patients undergoing elective unilateral VATS segmentectomy or lobectomy are randomly
      allocated to receive continuous nefopam infusion (n=45) or not (n=45), in addition to a
      standard postoperative analgesic regimen comprising of IV fentanyl-based patient-controlled
      analgesia (PCA). At the end of induction, the nefopam group will receive intravenous nefopam
      20mg mixed with 50ml of normal saline, and at the end of surgery this group will receive
      intravenous nefopam 60mg mixed with 50ml of normal saline at a rate of 2ml/hr. The control
      group will receive intravenous normal saline 50ml at the end of induction and receive
      intravenous normal saline 50ml at a rate of 2ml/hr.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: A prospective randomized double-blinded study
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
masking description: Outcomes assessor not involved in this study will investigate the outcomes. The patient will be not informed of the infusion of nefopam by not attaching an identifiable label so that it cannot be distinguished from normal saline.
measure: Total fentanyl consumption during 24 hours
time frame: postoperative 24 hours
description: postoperative fentanyl consumption (mcg) via IV patient controlled analgesia
measure: Total fentanyl consumption
time frame: postoperative 48 hours
description: postoperative fentanyl consumption (mcg) via IV patient controlled analgesia
measure: Postoperative pain score
time frame: postoperative 24, 48 hours
description: 11-pointed NRS pain score at resting/coughing/movement NRS (0-10): 0, "no pain"; 10, "worst pain imaginable"
measure: Postoperative nausea and vomiting
time frame: postoperative 24, 48 hours
description: Incidence of postoperative nausea and vomiting (%)
measure: chronic postsurgical pain
time frame: 3-months after surgery
description: Incidence of chronic postsurgical pain (NRS ≥ 3) (%)
arm group label: Nefopam group
arm group type: Experimental
description: At the end of induction, the nefopam group will receive intravenous nefopam 20mg mixed with 50ml of normal saline, and at the end of surgery, this group will receive intravenous nefopam 60mg mixed with 50ml of normal saline at a rate of 2ml/hr.
arm group label: Control group
arm group type: Placebo Comparator
description: The control group will receive intravenous normal saline 50ml at the end of induction and receive intravenous normal saline 50ml at a rate of 2ml/hr at the end of surgery.
intervention type: Drug
intervention name: Nefopam 80mg/day
description: continuous nefopam infusion
arm group label: Nefopam group
intervention type: Drug
intervention name: Normal saline
description: continuous normal saline infusion
arm group label: Control group
criteria: 
gender: All
minimum age: 19 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
country: Korea, Republic of
citation: Tirault M, Derrode N, Clevenot D, Rolland D, Fletcher D, Debaene B. The effect of nefopam on morphine overconsumption induced by large-dose remifentanil during propofol anesthesia for major abdominal surgery. Anesth Analg. 2006 Jan;102(1):110-7. doi: 10.1213/01.ANE.0000181103.07170.15.
PMID: 16368814
citation: Du Manoir B, Aubrun F, Langlois M, Le Guern ME, Alquier C, Chauvin M, Fletcher D. Randomized prospective study of the analgesic effect of nefopam after orthopaedic surgery. Br J Anaesth. 2003 Dec;91(6):836-41. doi: 10.1093/bja/aeg264.
PMID: 14633755
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Hojin Lee, MD
investigator title: Clinical assistant professor
mesh term: Pain, Postoperative
mesh term: Nefopam
sharing ipd: No