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NCT05871424 | Completed | Laparoscopic Cholecystectomy

Transdermal Buprenorphine Patch for Laparoscopic Cholecystectomy
Sponsor:

Gangnam Severance Hospital

Information provided by (Responsible Party):

Do-Hyeong Kim

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

Laparoscopic Cholecystectomy

Intervention/treatment

buprenorphine patch group

placebo group

Phase

Not Applicable

Study Type : Interventional
Estimated Enrollment : 66 participants
Masking : Double
Primary Purpose : Supportive Care
Official Title : Transdermal Buprenorphine Patch for Postoperative Pain Control in Laparoscopic Cholecystectomy: a Prospective Randomized, Placebo-controlled, Study
Actual Study Start Date : June 11, 2023
Estimated Primary Completion Date : February 14, 2024
Estimated Study Completion Date : February 14, 2024
Arm Intervention/treatment

Experimental: buprenorphine patch group

Drug: buprenorphine patch group

Sham Comparator: placebo group

Drug: placebo group
Ages Eligible for Study: 19 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
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
Transdermal Buprenorphine Patch for Laparoscopic Cholecystectomy

Location Details

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Transdermal Buprenorphine Patch for Laparoscopic Cholecystectomy

How to Participate

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Locations

Not yet recruiting

Korea, Republic of,

Gangnam Severance Hospital

Seoul, Korea, Republic of,