Comparing Opiranserin Plus Acetaminophen to Ibuprofen Plus Acetaminophen for Pain Relief After Minimally Invasive Gallbladder Surgery

What this Trial Is About

This research aims to compare two pain management approaches after minimally invasive gallbladder surgery. It evaluates whether the combination of opiranserin and acetaminophen is not worse than the combination of non-steroidal anti-inflammatory drugs NSAIDs and acetaminophen. The study is a single-center, randomized, controlled trial involving adult patients undergoing minimally invasive cholecystectomy. Participants are randomly assigned to one of two groups. In the opiranserin plus acetaminophen group, a 1000 mg infusion of opiranserin is given over 10 hours starting after anesthesia induction, with a loading dose over 30 minutes followed by maintenance infusion, plus intravenous acetaminophen 1 g every 8 hours for 24 hours after surgery. In the control group, participants receive a 500 ml normal saline infusion over 10 hours, along with intravenous acetaminophen 1 g and ibuprofen 300 mg every 8 hours for 24 hours postoperatively. During the study, participants are monitored for pain levels at rest and during movement at multiple time points up to 24 hours after surgery. Researchers measure the area under the curve of pain scores at rest for 12 and 24 hours, opioid use, time to first rescue analgesic, nausea incidence and severity, patient satisfaction, hospital stay length, and quality of recovery. The study includes safety monitoring and aims to assess the effectiveness and safety of these pain relief regimens following surgery.

Opiranserin for Minimally Invasive Cholecystectomy