About this trial
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
Qualifiers
Adult patient undergoing minimally invasive cholecystectomy
Disqualifiers
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
Trial design
Treatments tested in this trial
- Opiranserin+Acetaminophen
- Acetaminophen+NSAIDs