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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05871424
Other study ID # 3-2023-0007
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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