A Phase IV Randomized Trial of Maxigesic® Versus Standard Analgesia After Radical Gastrectomy

NCT07687394 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: 4-2026-0528
• Study Type: interventional
• Target: 160
• Locations: 0 countries
• Sites: N/A

Brief Summary

Background: Radical gastrectomy causes moderate-to-severe pain during the first 48 hours after surgery. Opioids are effective but carry adverse effects and risks of prolonged use, so ERAS-based care recommends multimodal analgesia. Acetaminophen is the most commonly used non-opioid analgesic in gastrectomy patients; adding ibuprofen as a fixed-dose combination has shown improved analgesia and opioid-sparing effects compared with acetaminophen alone in other surgical populations, but direct evidence in gastrectomy patients is limited. Objective: To evaluate whether scheduled administration of an acetaminophen-ibuprofen fixed-dose combination (Maxigesic® IV) is superior to acetaminophen alone for pain relief after radical gastrectomy, with exploratory assessment of cost-effectiveness and of differences in analgesic efficacy according to genetic polymorphisms. Hypothesis: When given on an identical scheduled regimen, the acetaminophen-ibuprofen fixed-dose combination produces significantly lower pain scores (NRS) over the first 48 postoperative hours than acetaminophen alone (superiority). Study plan: This is a phase IV, multicenter, double-blind, randomized controlled trial in which 160 gastric cancer patients scheduled for minimally invasive radical gastrectomy (80 per arm) are randomized 1:1 with stratification by institution. In both arms, the assigned drug is given as a 15-minute intravenous infusion every 6 hours, starting 30 minutes before the end of surgery through 48 hours postoperatively. The primary endpoint is the between-group difference in the time-weighted average (TWA) of repeatedly measured resting and active NRS over 48 hours, analyzed using a mixed model for repeated measures (MMRM); secondary endpoints include opioid consumption (MME), the Quality of Recovery score (QoR-15K), the incidence of chronic postsurgical pain (CPSP), and in-hospital costs.

Conditions

Stomach Neoplasms; Pain; Postoperative

Keywords

Gastrectomy

Outcome Measures

Primary Outcomes (1)

• Postoperative pain intensity (NRS)

  The primary endpoint is the between-group difference in postoperative pain intensity, measured with the 11-point Numerical Rating Scale (NRS; 0 = no pain, 10 = worst pain imaginable). Pain is assessed both at rest and on movement and is measured repeatedly over the first 48 hours after surgery (at rest from 0 to 48 hours; on movement from 6 to 48 hours). The treatment effect is evaluated as the between-group difference in the time-weighted average (TWA) of NRS over 0-48 hours, estimated using a mixed model for repeated measures (MMRM). A linear mixed model adjusting for covariates (e.g., extent of gastric resection) is performed as a supportive analysis to confirm the consistency of the results.

  At rest - 0 (immediately postoperatively), 2, 4, 6, 12, 18, 24, 30, 36, 42, and 48 hours after surgery; on movement - 6, 12, 18, 24, 30, 36, 42, and 48 hours after surgery

Secondary Outcomes (5)

• Total opioid consumption

  From the day of operation (day 0) to 72 hours after surgery

• Change in Quality of Recovery (QoR-15K)

  Preoperative, 24 hours aftery surgery, 48 hours after surgery, 72 hours after surgery

• Incidence of chronic postsurgical pain (CPSP)

  At 3 months after surgery (±14 days)

• (exploratory analysis) In-hospital cost

  Through discharge, an average of 5 days

• (exploratory analysis) Difference in analgesic efficacy according to genetic polymorphisms

  Genetic polymorphism assessed preoperatively. NRS scores measured through 72 hours after surgery.

Study Arms (2)

Acetaminophen

ACTIVE COMPARATOR

Participants receive acetaminophen alone (Newaminophen Premix, acetaminophen 1000 mg per 100 mL) as a 15-minute intravenous infusion every 6 hours, starting 30 minutes before the end of surgery and continuing through 48 hours after surgery (9 doses in total). The total daily acetaminophen dose does not exceed 4 g.

Drug: Acetaminophen (Newaminophen Premix)

Maxigesic

EXPERIMENTAL

Participants receive the acetaminophen-ibuprofen fixed-dose combination (Maxigesic IV, acetaminophen 1000 mg + ibuprofen 300 mg per 100 mL) on the same schedule as the comparator arm: a 15-minute intravenous infusion every 6 hours, starting 30 minutes before the end of surgery and continuing through 48 hours after surgery (9 doses in total). The total daily acetaminophen dose does not exceed 4 g.

Drug: Maxigesic IV (acetaminophen/ibuprofen)

Interventions

Acetaminophen (Newaminophen Premix) DRUG

As an active comparator, Newaminophen Premix 100 mL will be administered by 15-minute intravenous infusion every 6 hours during the first 48 hours after surgery.

Acetaminophen

Maxigesic IV (acetaminophen/ibuprofen) DRUG

Maxigesic 100 mL will be administered as a 15-minute intravenous infusion every 6 hours for the first 48 hours after surgery

Maxigesic

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 20 to 80 years diagnosed with gastric cancer by endoscopic biopsy who are scheduled for minimally invasive radical gastrectomy (laparoscopic or robotic)
• Patients scheduled for distal, proximal, or total gastrectomy among minimally invasive procedures (wedge resection, pylorus-preserving gastrectomy, and segmental gastrectomy are not eligible)
• Patients with an ECOG performance status of 0 or 1 and an ASA classification of I-III
• Patients who have voluntarily agreed to participate after receiving a full explanation of the study's purpose and content, and who have signed the written informed consent form approved by the Institutional Review Board
• Patients residing in Korea who are able to complete follow-up for 3 months after surgery

You may not qualify if:

• Patients with a reported history of hypersensitivity, allergy, or adverse reaction to NSAIDs, opioids, or acetaminophen
• Patients currently taking medications that may affect the study results, such as opioid or non-opioid analgesics, aspirin, warfarin or other anticoagulants, steroids, or high-dose hepatotoxic drugs
• Pregnant or breastfeeding patients
• Patients unable to read or understand the informed consent form
• Patients weighing less than 45 kg
• Patients scheduled for transfer to the intensive care unit instead of a general ward after surgery (ICU preparation)
• Patients scheduled for emergency surgery

Sponsors & Collaborators

• Yonsei University: lead

MeSH Terms

Conditions

Stomach Neoplasms; Pain

Interventions

Acetaminophen; Ibuprofen

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Hyoung-Il Kim, Professor

CONTACT

+82-2-2228-2100; cairus@yuhs.ac

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2026
• First Posted: July 7, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: July 7, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF