A Phase IV Randomized Trial of Maxigesic® Versus Standard Analgesia After Radical Gastrectomy
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age20-80
SponsorYonsei University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 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)
Trial design
Design model
Parallel
Treatments tested in this trial
Acetaminophen (Newaminophen Premix)
DrugAs 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)
DrugMaxigesic 100 mL will be administered as a 15-minute intravenous infusion every 6 hours for the first 48 hours after surgery
Treatment groups
160 Participants
are divided into 2 treatment groupsGroup A: AcetaminophenActive comparator 1 intervention
Group B: MaxigesicExperimental treatment 1 intervention
Trial outcomes
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.
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 surgerySecondary outcomes
1
Total opioid consumption
Total opioid consumption through 72 hours after surgery, expressed as morphine milligram equivalents (MME)
Time frame
From the day of operation (day 0) to 72 hours after surgery2
Change in Quality of Recovery (QoR-15K)
Change in the Korean version of the 15-item Quality of Recovery questionnaire (QoR-15K) from baseline.
Time frame
Preoperative, 24 hours aftery surgery, 48 hours after surgery, 72 hours after surgery3
Incidence of chronic postsurgical pain (CPSP)
Proportion of patients with chronic postsurgical pain, assessed using the Brief Pain Inventory-Korean (BPI-K).
Time frame
At 3 months after surgery (±14 days)4
(exploratory analysis) In-hospital cost
Total medical costs incurred during the hospital stay, compared between groups.
Time frame
Through discharge, an average of 5 daysLocations
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Source ClinicalTrials.gov
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