drugset / Trial / NCT07620665
Opiranserin for Minimally Invasive Cholecystectomy
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2026-06-10
- Primary completion
- 2028-05-25
- Completion
- 2028-05-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Ibuprofen | Small molecule | 300 mg | — |
| Subject | Opiranserin | Unknown | 840 mg | — |
| Comparator | Acetaminophen | Small molecule | 1 g | Intravenous |
Indications
No indication recorded.