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Transdermal Buprenorphine Patch for Laparoscopic Cholecystectomy

Y

Yonsei University Health System (YUHS)

Status

Completed

Conditions

Laparoscopic Cholecystectomy

Treatments

Drug: buprenorphine patch group
Drug: placebo group

Study type

Interventional

Funder types

Other

Identifiers

NCT05871424
3-2023-0007

Details and patient eligibility

About

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.

Enrollment

66 patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

66 participants in 2 patient groups

buprenorphine patch group
Experimental group
Treatment:
Drug: buprenorphine patch group
placebo group
Sham Comparator group
Treatment:
Drug: placebo group

Trial contacts and locations

1

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Central trial contact

Do-Hyeong Kim

Data sourced from clinicaltrials.gov

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