Transdermal Buprenorphine Patch for Laparoscopic Cholecystectomy

Laparoscopic Cholecystectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05871424
• Other study ID #: 3-2023-0007
• Status: Completed
• Phase: N/A
• Start date: June 11, 2023
• Est. completion date: February 14, 2024

Study information

• Verified date: February 2024
• Source: Gangnam Severance Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: February 14, 2024
• Est. primary completion date: February 14, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Laparoscopic Cholecystectomy

Intervention

Drug:
• buprenorphine patch group
5 mcg/h buprenorphine patch will be applied preoperatively
• placebo group
simple dressing tape only will be applied

Locations

Country	Name	City	State
Korea, Republic of	Gangnam Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Gangnam Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	6 hours after surgery
Secondary	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.	up to 2 weeks after the surgery