Maxigesic for Postoperative Pain Control After Laparoscopic or Robotic Gastrectomy

Overview

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.

Postoperative pain management is an important component of recovery after gastrectomy. Opioids are commonly used for the treatment of acute postoperative pain; however, opioid-related adverse effects and concerns regarding excessive opioid exposure have increased interest in multimodal analgesic strategies that combine non-opioid analgesics. Maxigesic is an intravenous fixed-dose combination of acetaminophen 1,000 mg and ibuprofen 300 mg. This study is designed to evaluate whether perioperative administration of Maxigesic provides effective postoperative analgesia and reduces the need for opioid and rescue analgesics compared with intravenous acetaminophen alone in patients undergoing minimally invasive gastrectomy for gastric cancer. A total of 90 adult participants scheduled to undergo laparoscopic or robotic gastrectomy will be randomly assigned in a 1:1 ratio to the Maxigesic group or the acetaminophen control group. Participants assigned to the Maxigesic group will receive intravenous Maxigesic at the initiation of anesthesia and subsequently at 6-hour intervals after surgery through 72 hours after surgery. Participants assigned to the control group will receive intravenous acetaminophen 1,000 mg at 6-hour intervals according to the postoperative analgesic protocol. Postoperative patient-controlled analgesia containing fentanyl will be available, and additional rescue analgesics may be administered as clinically indicated. Postoperative pain intensity will be assessed using the Numeric Rating Scale (NRS) immediately after surgery and at 12, 24, 48, and 72 hours after surgery. The primary efficacy outcome is the sum of pain intensity differences over the first 72 postoperative hours (SPID72). Secondary efficacy outcomes include NRS pain scores at predefined postoperative time points, total opioid consumption during the first 48 hours, the number of rescue analgesic administrations during the first 48 hours, and the use of antiemetic medications during the first 48 hours. Safety will be evaluated through the assessment of adverse events until postoperative day 5 or hospital discharge.