Maxigesic for Postoperative Pain Control After Laparoscopic or Robotic Gastrectomy

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.

Inclusion criteria

• Adults aged 19 years or older at the time of written informed consent.
• Patients scheduled to undergo laparoscopic or robotic gastrectomy for gastric cancer.
• American Society of Anesthesiologists (ASA) physical status class I to III.
• Patients who voluntarily decide to participate after receiving a detailed explanation of the study and provide written informed consent.

Exclusion criteria

• Patients who do not undergo laparoscopic or robotic gastrectomy.
• Patients who require conversion to open surgery.
• Known hypersensitivity to any component of the study medications.
• Any contraindication to the use of the study medications according to the prescribing information.
• Women who are pregnant or breastfeeding, or who plan to become pregnant during the study period.
• Participants or their partners who do not agree to use a medically acceptable method of contraception during the study period.