Comparison of Opiranserin/Acetaminophen Versus Ibuprofen/Acetaminophen for Postoperative Pain Management After Minimally Invasive Cholecystectomy: A Randomized, Controlled, Non-inferiority Trial
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The purpose of this study is to evaluate whether the combination therapy of opiranserin and acetaminophen is non-inferior to the combination of non-steroidal anti-inflammatory drugs (NSAIDs) and acetaminophen for postoperative pain management after minimally invasive cholecystectomy. This is a single-center, randomized, controlled, non-inferiority clinical trial in adult patients undergoing minimally invasive cholecystectomy. Participants will be randomly assigned to either the Treatement group (opiranserin + acetaminophen) or the control group (NSAIDs + acetaminophen) in a 1:1 ratio to compare the analgesic efficacy and safety between the two analgesic regimens.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:
• Adult patient undergoing minimally invasive cholecystectomy
Locations
Other Locations
Republic of Korea
Gangnam Severance Hospital
RECRUITING
Seoul
Gangnam Severance Hospital
NOT_YET_RECRUITING
Seoul
Contact Information
Primary
Young Song
NEARMYHEART@yuhs.ac
02-2019-6692
Time Frame
Start Date: 2026-06-10
Estimated Completion Date: 2028-05-30
Participants
Target number of participants: 88
Treatments
Experimental: Opiranserin+Acetaminophen group
In the Opiranserin+Acetaminophen group, opiranserine 1000mg infusion will be provided over 10 hr. IV Acetaminophen 1g will be provided q 8h until 24 h potperatively.
Active_comparator: Acetaminophen+NSAIDs group
In the Acetaminophen+NSAIDs group, Normal saline 500 ml will be provided over 10hr. IV Acetaminophen 1g and ibuprofen 300mg will be provided q 8h until 24 h potperatively.
Related Therapeutic Areas
Sponsors
Leads: Gangnam Severance Hospital