Maxigesic for Postoperative Pain Control After Laparoscopic or Robotic Gastrectomy | NCT07768514 | Trialant

Active, not recruitingInterventionalPhase 2Updated Aug 17, 2026

Maxigesic for Postoperative Pain Control After Laparoscopic or Robotic Gastrectomy

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

Overview

Key facts that identify this study and show where it stands today.

ClinicalTrials.gov ID: NCT07768514
Lead Sponsor: Seoul National University Bundang HospitalOTHER
Overall Status: Active, not recruiting
Study Type: Interventional
Phase: Phase 2
Enrollment: 90Actual
Last Update Posted: Aug 17, 2026Actual
Start Date: Nov 21, 2025Actual
Primary Completion Date: Nov 8, 2026Estimated
Completion Date: Dec 25, 2026Estimated

Description

What the study is about and why it is being run, in the researchers' own words.

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
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.
Detailed Description

Conditions

The medical conditions and diseases this study investigates.

Stomach Neoplasms

Interventions

The treatments and procedures being evaluated in this study.

Acetaminophen and Ibuprofen
Acetaminophen

Participation

Who can join this study and the criteria used to decide.

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility Criteria: 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.

Design

How the study is designed and how its participant groups are organized.

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Contacts

The people to reach with questions about this study or how to join it.

No central contacts

There are no central contacts for this study.

Locations

Where the study is run and whether each site is currently recruiting.

Seoul National University Bundang Hospital

Seongam, Gyeonggi-do 13620, South Korea

Collaborators

The organizations and people involved in this study.

Lead Sponsor: Seoul National University Bundang HospitalOTHER
Collaborators

Similar Studies

Other registered studies that closely resemble this one.

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.