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

Sponsor
Yonsei University
Study ID
NCT07687394
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Pain
  • Postoperative
  • Stomach Neoplasms

Eligibility Criteria

Sex
ALL
Age
20 Years - 80 Years
Healthy Volunteers
Not accepted

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.
  • 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

Study Details

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.

Key Dates

First listed
Jul 7, 2026
Start date
Jul 1, 2026
Status verified
Jun 2026
Primary completion
Oct 1, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
160 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Acetaminophen
    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.
  • Experimental: Maxigesic
    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.

Primary Outcome Measure

Postoperative pain intensity (NRS) [ Time Frame: 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 ]

Central Contacts

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