Opiranserin for Minimally Invasive Cholecystectomy

Sex: All

Ages: 19 Years – N/A

Healthy volunteers: No

Phase: NA

Enrollment: 88

Sponsor: Gangnam Severance Hospital

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 Criteria

Inclusion Criteria: * Adult patient undergoing minimally invasive cholecystectomy Exclusion Criteria: * Known hypersensitivity or allergy to acetaminophen, NSAIDs, opiranserin, or fentanyl. * pre-existing chronic pain, * clinically significant ECG findings (QRS \> 200 msec, QTcF \>450 msec) * severe renal impairment * severe hepatic impairment

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07620665). StuddyBuddy aggregates publicly available trial information.