Transdermal Buprenorphine Patch for Laparoscopic Cholecystectomy

February 23, 2024 updated by: Do-Hyeong Kim, Gangnam Severance Hospital

Transdermal Buprenorphine Patch for Postoperative Pain Control in Laparoscopic Cholecystectomy: a Prospective Randomized, Placebo-controlled, Study

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: buprenorphine patch group
Drug: buprenorphine patch group
5 mcg/h buprenorphine patch will be applied preoperatively
Sham Comparator: placebo group
Drug: placebo group
simple dressing tape only will be applied

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numeric rating scale pain score at movement
Time Frame: 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)
6 hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numeric rating scale pain score at rest
Time Frame: 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.
up to 2 weeks after the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gangnam Severance Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 11, 2023

Primary Completion (Actual)

February 14, 2024

Study Completion (Actual)

February 14, 2024

Study Registration Dates

First Submitted

March 12, 2023

First Submitted That Met QC Criteria

May 12, 2023

First Posted (Actual)

May 23, 2023

Study Record Updates

Last Update Posted (Estimated)

February 26, 2024

Last Update Submitted That Met QC Criteria

February 23, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3-2023-0007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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