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Maxigesic for Postoperative Pain Control After Laparoscopic or Robotic Gastrectomy
Sponsor: Seoul National University Bundang Hospital
Summary
This prospective, randomized, phase 4 clinical trial aims to evaluate the efficacy and safety of intravenous Maxigesic, a fixed-dose combination of acetaminophen and ibuprofen, for postoperative pain control in patients undergoing laparoscopic or robotic gastrectomy for gastric cancer. A total of 90 participants will be randomly assigned to receive either Maxigesic or intravenous acetaminophen. The primary objective is to compare postoperative pain control between the two groups using the sum of pain intensity differences over 72 hours (SPID72). Secondary outcomes include postoperative pain scores, opioid consumption, rescue analgesic use, antiemetic use, and safety outcomes.
Official title: Prospective Randomized Trial to Evaluate the Efficacy and Safety of Maxigesic Injection for Post-operative Pain Control in Patients Who Have Undergone Laparoscopic or Robotic Gastrectomy
Key Details
Gender
All
Age Range
19 Years - Any
Study Type
INTERVENTIONAL
Enrollment
90
Start Date
2025-11-21
Completion Date
2026-12-25
Last Updated
2026-08-17
Healthy Volunteers
No
Conditions
Interventions
Acetaminophen and Ibuprofen
Maxigesic is a fixed-dose combination containing acetaminophen 1,000 mg and ibuprofen 300 mg in 100 mL. One vial is administered intravenously over 15 minutes at the initiation of anesthesia, followed by administration at 6-hour intervals during the postoperative treatment period through 72 hours after surgery.
Acetaminophen
Acetaminophen 1,000 mg is administered intravenously over 15 minutes every 6 hours, four times daily, from postoperative day 0 through postoperative day 2. The maximum daily dose does not exceed 4,000 mg.
Locations (1)
Seoul National University Bundang Hospital
Seongam, Gyeonggi-do, South Korea