Transdermal Buprenorphine Patch for Laparoscopic Cholecystectomy

Gangnam Severance Hospital66 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

Conditions

Laparoscopic Cholecystectomy

Interventions

buprenorphine patch groupDRUG

5 mcg/h buprenorphine patch will be applied preoperatively

placebo groupDRUG

simple dressing tape only will be applied

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (1)

Gangnam Severance Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Numeric rating scale pain score at movement

Pain intensity at rest will be evaluated by an 11-point numeric rating scale (NRS: 0 = no pain, 10 = worst imaginable pain)

Time frame: 6 hours after surgery

Secondary Outcomes

Numeric rating scale pain score at rest

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.

Time frame: up to 2 weeks after the surgery

Data from ClinicalTrials.gov

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