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

NCT04450355 | Completed DMC

• 1 other identifier: 2001-036-1092
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain

Keywords

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• Total fentanyl consumption during 24 hours

  postoperative fentanyl consumption (mcg) via IV patient controlled analgesia

  postoperative 24 hours

Secondary Outcomes (4)

• Total fentanyl consumption

  postoperative 48 hours

• Postoperative pain score

  postoperative 24, 48 hours

• Postoperative nausea and vomiting

  postoperative 24, 48 hours

• chronic postsurgical pain

  3-months after surgery

Study Arms (2)

Nefopam group

EXPERIMENTAL

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

Control group

PLACEBO COMPARATOR

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

Interventions

Nefopam 80mg/day DRUG

continuous nefopam infusion

Nefopam group

Normal saline DRUG

continuous normal saline infusion

Control group

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Pharmbio Korea: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, KS013, South Korea

Location

Related Publications (2)

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Nefopam; Saline Solution

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Oxazocines; Azocines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical assistant professor

Model Details: A prospective randomized double-blinded study

Study Record Dates

• First Submitted: June 24, 2020
• First Posted: June 29, 2020
• Study Start: July 30, 2020
• Primary Completion: August 9, 2021
• Study Completion: November 10, 2021
• Last Updated: May 6, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)