Nefopam as a Multimodal Analgesia for Thoracic Surgery

February 12, 2023 updated by: Eunah Cho, MD, Kangbuk Samsung Hospital

Nefopam as a Multimodal Analgesia for Video-assisted Thoracoscopic Surgery

Acute postoperative pain after video-assisted thoracoscopic surgery is very severe. Because pain after thoracic surgery prevents early recovery, and increases postoperative complications, its is important to prevent pain after video-assisted thoracoscopic surgery. In the present study, we will evaluate whether nefopam reduces pain after video-assisted thoracoscopic surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patient scheduled for elective video-assisted thoracoscopic surgery
  • American Society of Anesthesiologists physical grade I, II, III
  • patient aged from 18 years old

Exclusion Criteria:

  • history of allergy in nonsteroidal anti-inflammatory drugs, or nefopam
  • renal insufficiency
  • liver insufficiency
  • myocardial infarction
  • glaucoma
  • pregnant and lactating women at the time of surgery
  • patient who did not consent to the use of patient-controlled analgesia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: control group
Nefopam will not be administered in this group.
EXPERIMENTAL: nefopam group
Intravenous nefopam 20 mg will be administered twice, immediately after induction of anesthesia and at the end of surgery.
Drug: Nefopam

Nefopam 20 mg is mixed to 100 mL of normal saline, and is infused intravenously over 15 minutes.

20 mg of nefopam is administered intravenously for two times, after induction and at the end of surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain after 1 hour of surgery
Time Frame: 1 hour after surgery.
Acute postoperative pain will be assessed using numerical rating scale from 0 (no pain) to 10 (worst pain ever).
1 hour after surgery.
Pain after 6 hour of surgery
Time Frame: 6 hours hours after surgery.
Acute postoperative pain will be assessed using numerical rating scale from 0 (no pain) to 10 (worst pain ever).
6 hours hours after surgery.
Pain after 12 hour of surgery
Time Frame: 12 hours after surgery.
Acute postoperative pain will be assessed using numerical rating scale from 0 (no pain) to 10 (worst pain ever).
12 hours after surgery.
Pain after 24 hour of surgery
Time Frame: 24 hours after surgery.
Acute postoperative pain will be assessed using numerical rating scale from 0 (no pain) to 10 (worst pain ever).
24 hours after surgery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient-controlled analgesia use
Time Frame: 24 hours after surgery
Fentanyl consumption administered thorough the patient-controlled analgesia machine.
24 hours after surgery
Rescue analgesics
Time Frame: 24 hours after surgery.
Additional analgesic use during postoperative period.
24 hours after surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kangbuk Samsung Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 8, 2021

Primary Completion (ACTUAL)

September 23, 2022

Study Completion (ACTUAL)

September 23, 2022

Study Registration Dates

First Submitted

August 17, 2021

First Submitted That Met QC Criteria

December 20, 2021

First Posted (ACTUAL)

December 29, 2021

Study Record Updates

Last Update Posted (ESTIMATE)

February 14, 2023

Last Update Submitted That Met QC Criteria

February 12, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NEVATS2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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