RecruitingNot ApplicableNCT07620665

Opiranserin for Minimally Invasive Cholecystectomy

Comparison of Opiranserin/Acetaminophen Versus Ibuprofen/Acetaminophen for Postoperative Pain Management After Minimally Invasive Cholecystectomy: A Randomized, Controlled, Non-inferiority Trial


Sponsor

Gangnam Severance Hospital

Enrollment

88 participants

Start Date

Jun 10, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Acetaminophen+NSAIDs and a drug called Opiranserin+Acetaminophen for people with cholecystectomy, laparoscopic and cholecystectomy, robotic. The study is currently recruiting participants at 2 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOpiranserin+Acetaminophen

In the Opiranserin+Acetaminophen group, opiranserine 1000mg infusion will be provided over 10 hr. Opiranserin infusion will be started after the indduction of anesthesia. After laoding dose (160mg ) over 30 minutes, maintenace dose (840mg) will be infused over 9hr 30min. IV Acetaminophen 1g will be provided q 8h until 24 h potperatively.

DRUGAcetaminophen+NSAIDs

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.


Locations(2)

Gangnam Severance Hospital

Seoul, South Korea

Gangnam Severance Hospital

Seoul, South Korea

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NCT07620665


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