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OpenTrials
Completed

NCT Number: NCT04450355

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

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.

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Key information

Age range

19 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, KS013, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nefopam 80mg/day

Drug

continuous nefopam infusion

normal saline

Drug

continuous normal saline infusion

Primary outcomes

  1. Total fentanyl consumption during 24 hours

    Time frame: postoperative 24 hours

    postoperative fentanyl consumption (mcg) via IV patient controlled analgesia

Secondary outcomes

  1. Total fentanyl consumption

    Time frame: postoperative 48 hours

    postoperative fentanyl consumption (mcg) via IV patient controlled analgesia

  2. 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"

  3. Postoperative nausea and vomiting

    Time frame: postoperative 24, 48 hours

    Incidence of postoperative nausea and vomiting (%)

  4. chronic postsurgical pain

    Time frame: 3-months after surgery

    Incidence of chronic postsurgical pain (NRS ≥ 3) (%)

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Pharmbio Korea

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 29, 2020
Registry last updated
May 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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