Transdermal Buprenorphine Patch for Laparoscopic Cholecystectomy

Not Applicable

Completed

• Conditions: Laparoscopic Cholecystectomy
• Interventions: Drug: buprenorphine patch group; Drug: placebo group

• Registration Number: NCT05871424
• Lead Sponsor: Gangnam Severance Hospital

Brief Summary

Preliminary studies of the transdermal buprenorphine patch target chronic pain patients, and the pain relief effect and safety have been proven. There are previous reports that the transdermal buprenorphine patch is effective in acute postoperative pain control. However, no clinical studies have yet been reported on its application during laparoscopic cholecystectomy. Therefore, we designed this study to see if the use of a transdermal buprenorphine patch resulted in a better pain profile.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-12
• Study First Submitted QC: 2023-05-12
• Study First Posted: 2023-05-23
• Study Start: 2023-06-11
• Status Verified: 2024-02
• Primary Completion: 2024-02-14
• Study Completion: 2024-02-14
• Last Update Submitted: 2024-02-23
• Last Update Posted: 2024-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

• 1. Patients 19 years of age or older who are expected to undergo laparoscopic cholecystectomy 2) ASA PS 1-3

Exclusion Criteria

• (1) Patients with known hypersensitivity to buprenorphine, including patients with previous allergic contact dermatitis (2) Patients with drug resistance, opioid dependence, and treatment for drug withdrawal symptoms (3) Patients with severe respiratory dysfunction or respiratory depression (4) Patients currently taking other central nervous system depressants or muscle relaxants that may cause respiratory depression, hypotension, severe sedation, or lead to coma (5) If you are unable to read or understand the consent form (e.g. cognitive impairment, illiteracy, foreigners, etc.) (6) Other vulnerable subjects

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
buprenorphine patch group	buprenorphine patch group	-
placebo group	placebo group	-

Primary Outcome Measures

Name	Time	Method
Numeric rating scale pain score at movement	6 hours after surgery	Pain intensity at rest will be evaluated by an 11-point numeric rating scale (NRS: 0 = no pain, 10 = worst imaginable pain)

Secondary Outcome Measures

Name	Time	Method
Numeric rating scale pain score at rest	up to 2 weeks after the surgery	Pain intensity at rest will be evaluated by an 11-point numeric rating scale (NRS: 0 = no pain, 10 = worst imaginable pain) 1, 2, 6, 24, and 2 weeks after the surgery.

Trial Locations

Locations (1)

Gangnam Severance Hospital; 🇰🇷 Seoul, Korea, Republic of