Effects of Continuous Infusion of Intravenous Nefopam on Postoperative Pain and Opioid Consumption After VATS

Overview

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.

Full Title of Study: “Effects of Continuous Infusion of Intravenous Nefopam on Postoperative Pain and Opioid Consumption After Video Assisted Thoracic Surgery: A Double Blind Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: February 28, 2021

Detailed Description

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.

Interventions

  • Drug: Nefopam 80mg/day
    • continuous nefopam infusion
  • Drug: Normal saline
    • continuous normal saline infusion

Arms, Groups and Cohorts

  • Experimental: Nefopam group
    • 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.
  • Placebo Comparator: Control group
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Total fentanyl consumption during 24 hours
    • Time Frame: postoperative 24 hours
    • postoperative fentanyl consumption (mcg) via IV patient controlled analgesia

Secondary Measures

  • Total fentanyl consumption
    • Time Frame: postoperative 48 hours
    • postoperative fentanyl consumption (mcg) via IV patient controlled analgesia
  • Postoperative pain score
    • Time Frame: postoperative 24, 48 hours
    • 11-pointed NRS pain score at resting/coughing/movement NRS (0-10): 0, “no pain”; 10, “worst pain imaginable”
  • Postoperative nausea and vomiting
    • Time Frame: postoperative 24, 48 hours
    • Incidence of postoperative nausea and vomiting (%)
  • chronic postsurgical pain
    • Time Frame: 3-months after surgery
    • Incidence of chronic postsurgical pain (NRS ≥ 3) (%)

Participating in This Clinical Trial

Inclusion Criteria

  • Patients scheduled to undergo elective unilateral VATS segmentectomy or lobectomy under general anesthesia
  • American Society of Anesthesiologists (ASA) physical classification I-II
  • Consent to IV-patient controlled analgesia use
  • Willingness and ability to sign an informed consent document

Exclusion Criteria

  • Do not understand our study
  • Allergies to anesthetic or analgesic medications
  • Continuous local anesthetics infiltration for postoperative pain control
  • Patients who receive mechanical ventilation more than 2 hours after surgery
  • Pregnancy/Breast feeder
  • Medical or psychological disease that can affect the treatment response

Gender Eligibility: All

Minimum Age: 19 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Seoul National University Hospital
  • Collaborator
    • Pharmbio Korea
  • Provider of Information About this Clinical Study
    • Principal Investigator: Hojin Lee, MD, Clinical assistant professor – Seoul National University Hospital
  • Overall Contact(s)
    • Hojin Lee, MD, 82-2-2072-2467, zenerdiode03@gmail.com

References

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.

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.

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