Transdermal Buprenorphine Patch for Laparoscopic Cholecystectomy

• Sponsor: Gangnam Severance Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05871424
• Collaborator: (none)
• Enrollment: 66
• Arms: 2
• Anticipated Duration (Months): 12

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Laparoscopic Cholecystectomy	Drug: buprenorphine patch group; Drug: placebo group	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 66 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: Transdermal Buprenorphine Patch for Postoperative Pain Control in Laparoscopic Cholecystectomy: a Prospective Randomized, Placebo-controlled, Study
• Anticipated Study Start Date: May 30, 2023
• Anticipated Primary Completion Date: May 30, 2024
• Anticipated Study Completion Date: May 30, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Gangnam Severance Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gangnam Severance Hospital
• ClinicalTrials.gov Identifier: NCT05871424
• Other Study ID Numbers: 3-2023-0007
• First Posted: May 23, 2023
• Last Update Posted: May 23, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Buprenorphine

Study Results

No Results Posted as of May 23, 2023