None listed
Conditions
Interventions
Drug : In this double-blind trial, participants are randomized 1:1 to receive either the acetaminophen–ibuprofen fixed-dose combination (Maxigesic® IV
acetaminophen 1000 mg + ibuprofen 300 mg per 100 mL vial
experimental arm) or acetaminophen alone (Newaminophen Premix®
acetaminophen 1000 mg per 100 mL
control arm). In both arms, the assigned drug is administered as a 15-minute intravenous infusion every 6 hours on an identical schedule—starting 30 minutes before the end of surgery and continuing th
Sponsors
Yonsei University Health System, Severance Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: - 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) - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Repeatedly measured pain scores at rest and on movement (Numerical Rating Scale, NRS) over the first 48 hours after surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Total opioid consumption through 72 hours after surgery, expressed as morphine milligram equivalents (MME);Change in the Quality of Recovery score (QoR-15K);Incidence of chronic postsurgical pain (CPSP) assessed using the Brief Pain Inventory–Korean (BPI-K);In-hospital costs incurred during hospitalization | — |
Countries
Korea, Republic of
Contacts
Public ContactJawon Hwang
Yonsei University
Outcome results
None listed