Maxigesic for Postoperative Pain Control After Laparoscopic or Robotic Gastrectomy

NCT07768514 | Active Not Recruiting Phase 2

• 1 other identifier: Maxi
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stomach Neoplasms

Outcome Measures

Primary Outcomes (1)

• Sum of Pain Intensity Differences Over 72 Hours (SPID72)

  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).

  From immediately after surgery through 72 hours after surgery

Secondary Outcomes (4)

• Postoperative Pain Intensity Assessed by Numeric Rating Scale (NRS)

  Immediately after surgery and at 12, 24, and 48 hours after surgery

• Number of Antiemetic Administrations

  From the end of surgery through 48 hours after surgery

• Total Opioid Consumption

  From the end of surgery through 48 hours after surgery

• Number of Rescue Analgesic Administrations

  From the end of surgery through 48 hours after surgery

Study Arms (2)

Maxigesic Arm

EXPERIMENTAL

Participants receive intravenous Maxigesic (acetaminophen 1,000 mg/ibuprofen 300 mg in 100 mL) beginning at the initiation of anesthesia and subsequently at 6-hour intervals during the postoperative treatment period through 72 hours, according to the study protocol. Postoperative fentanyl-based patient-controlled analgesia (PCA) is also provided.

Drug: Acetaminophen and Ibuprofen

Acetaminophen Arm

ACTIVE COMPARATOR

Participants receive intravenous acetaminophen 1,000 mg every 6 hours, four times daily, from postoperative day 0 through postoperative day 2, with a maximum daily dose of 4,000 mg. Postoperative fentanyl-based patient-controlled analgesia (PCA) is also provided.

Drug: Acetaminophen

Interventions

Acetaminophen and Ibuprofen DRUG

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.

Also known as: Maxigesic

Maxigesic Arm

Acetaminophen DRUG

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.

Acetaminophen Arm

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead
• KB Pharma: collaborator

Study Sites (1)

Seoul National University Bundang Hospital

Seongam, Gyeonggi-do, 13620, South Korea

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Acetaminophen; Ibuprofen

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 12, 2026
• First Posted: August 17, 2026
• Study Start: November 21, 2025
• Primary Completion (Estimated): November 8, 2026
• Study Completion (Estimated): December 25, 2026
• Last Updated: August 17, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)