NCT07687394Not yet recruitingPhase 4
A Phase IV Randomized Trial of Maxigesic® Versus Standard Analgesia After Radical Gastrectomy
A Phase IV, Multicenter, Double-blind, Randomized Controlled Trial to Evaluate the Superiority of Maxigesic® Over Standard Analgesia in Patients Undergoing Radical Gastrectomy
Source: ClinicalTrials.gov · Last updated 7 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 160 (estimated)
- First submitted
- 18 Jun 2026
- Start date
- 1 Jul 2026
- Primary completion date
- 1 Oct 2028
- Lead sponsor
- Yonsei University
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT07687394
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 160
- From 1 Jul 2026 to the primary completion date, 1 Oct 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Patients scheduled for transfer to the intensive care unit instead of a general ward after surgery (ICU preparation)
- Patients scheduled for emergency surgery
Other illness
- Patients with a reported history of hypersensitivity, allergy, or adverse reaction to NSAIDs, opioids, or acetaminophen
- Patients with a contraindication to NSAIDs or acetaminophen identified from medical history or preoperative evaluation-for example, active liver disease, heart failure, chronic kidney disease, thrombocytopenia, or a history of asthma (peptic ulcer disease is not an exclusion criterion)
Other
- Pregnant or breastfeeding patients
- Patients unable to read or understand the informed consent form
- Patients weighing less than 45 kg
Who the study is looking for
- 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
Age in the registry: 20 years to 80 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.