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.
Study 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.
Eligibility
Sex
ALL
Min age
19 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Sum of Pain Intensity Differences Over 72 Hours (SPID72) — From immediately after surgery through 72 hours after surgery 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 outcome is the sum of pain intensity differences over the first 72 postoperative hours (SPID72).
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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