Transdermal Buprenorphine Patch for Laparoscopic Cholecystectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-11

Study Completion Date

2024-02-14

Brief Summary

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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.

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Detailed Description

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Conditions

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Laparoscopic Cholecystectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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buprenorphine patch group

Group Type EXPERIMENTAL

buprenorphine patch group

Intervention Type DRUG

5 mcg/h buprenorphine patch will be applied preoperatively

placebo group

Group Type SHAM_COMPARATOR

placebo group

Intervention Type DRUG

simple dressing tape only will be applied

Interventions

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buprenorphine patch group

5 mcg/h buprenorphine patch will be applied preoperatively

Intervention Type DRUG

placebo group

simple dressing tape only will be applied

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No