Nefopam as a Multimodal Analgesia for Thoracic Surgery

NCT05173337 | Completed

• 1 other identifier: NEVATS2
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (4)

• Pain after 1 hour of 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

  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

  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

  Acute postoperative pain will be assessed using numerical rating scale from 0 (no pain) to 10 (worst pain ever).

  24 hours after surgery.

Secondary Outcomes (2)

• Patient-controlled analgesia use

  24 hours after surgery

• Rescue analgesics

  24 hours after surgery.

Study Arms (2)

control group

NO INTERVENTION

Nefopam will not be administered in this group.

nefopam group

EXPERIMENTAL

Intravenous nefopam 20 mg will be administered twice, immediately after induction of anesthesia and at the end of surgery.

Drug: Nefopam

Interventions

Nefopam DRUG

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.

nefopam group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kangbuk Samsung Hospital: lead

Study Sites (1)

Eunah Cho

Seoul, 03181, South Korea

Location

Related Publications (1)

• Ki HS, Shim JG, Choi HK, Ryu KH, Kang DY, Park J, Ahn JH, Lee SH, Cho EA. Nefopam as a multimodal analgesia in thoracoscopic surgery: a randomized controlled trial. J Thorac Dis. 2024 Jun 30;16(6):3644-3654. doi: 10.21037/jtd-24-30. Epub 2024 Jun 12.

  PMID: 38983158 DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Nefopam

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Oxazocines; Azocines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 17, 2021
• First Posted: December 29, 2021
• Study Start: December 8, 2021
• Primary Completion: September 23, 2022
• Study Completion: September 23, 2022
• Last Updated: February 14, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)