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

Sponsor
Seoul National University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04450355
Collaborator
Pharmbio Korea (Other)
90
Enrollment
1
Location
2
Arms
15.4
Actual Duration (Months)
5.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Nefopam 80mg/day
  • Drug: Normal saline
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
A prospective randomized double-blinded studyA prospective randomized double-blinded study
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.
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jul 30, 2020
Actual Primary Completion Date :
Aug 9, 2021
Actual Study Completion Date :
Nov 10, 2021

Arms and Interventions

Arm Intervention/Treatment
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.

Drug: Nefopam 80mg/day
continuous nefopam infusion
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.

Drug: Normal saline
continuous normal saline infusion

Outcome Measures

Primary Outcome Measures

  1. Total fentanyl consumption during 24 hours [postoperative 24 hours]

    postoperative fentanyl consumption (mcg) via IV patient controlled analgesia

Secondary Outcome Measures

  1. Total fentanyl consumption [postoperative 48 hours]

    postoperative fentanyl consumption (mcg) via IV patient controlled analgesia

  2. Postoperative pain score [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 [postoperative 24, 48 hours]

    Incidence of postoperative nausea and vomiting (%)

  4. chronic postsurgical pain [3-months after surgery]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Seoul National University Hospital Seoul Korea, Republic of KS013

Sponsors and Collaborators

  • Seoul National University Hospital
  • Pharmbio Korea

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Hojin Lee, MD, Clinical assistant professor, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT04450355
Other Study ID Numbers:
  • 2001-036-1092
First Posted:
Jun 29, 2020
Last Update Posted:
May 6, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hojin Lee, MD, Clinical assistant professor, Seoul National University Hospital
Postoperative Pain
Additional relevant MeSH terms:
Pain, Postoperative
Nefopam

Study Results

No Results Posted as of May 6, 2022