[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100646779":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":26,"responsibleParty":37,"collaborators":26,"id":39,"slug":40,"hasResults":41,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":26,"eligibilityCriteria":45,"healthyVolunteers":41,"sex":46,"minAge":47,"maxAge":48,"enrollmentInfo":49,"targetDuration":26,"studyType":52,"phases":53,"briefSummary":55,"conditions":56,"keywords":60,"overallStatus":62,"whyStopped":26,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":26},{"fullName":5,"class":6},"Yonsei University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Drug: Acetaminophen (Newaminophen Premix)",{"label":15,"type":16,"description":17,"interventionNames":18},"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.",[19],"Drug: Maxigesic IV (acetaminophen\u002Fibuprofen)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Acetaminophen (Newaminophen Premix)","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.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Maxigesic IV (acetaminophen\u002Fibuprofen)","Maxigesic 100 mL will be administered as a 15-minute intravenous infusion every 6 hours for the first 48 hours after surgery",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Hyoung-Il Kim, Professor","CONTACT","+82-2-2228-2100","cairus@yuhs.ac",{"type":38,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100646779","phase-4-a-phase-iv-randomized-trial-of-maxigesic-versus-standard-analgesia-after-radical-gastrectomy-100646779",false,"NCT07687394","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","Inclusion Criteria:\n\n* Patients aged 20 to 80 years diagnosed with gastric cancer by endoscopic biopsy who are scheduled for minimally invasive radical gastrectomy (laparoscopic or robotic)\n* Patients scheduled for distal, proximal, or total gastrectomy among minimally invasive procedures (wedge resection, pylorus-preserving gastrectomy, and segmental gastrectomy are not eligible)\n* Patients with an ECOG performance status of 0 or 1 and an ASA classification of I-III\n* 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\n* Patients residing in Korea who are able to complete follow-up for 3 months after surgery\n\nExclusion Criteria:\n\n* Patients with a reported history of hypersensitivity, allergy, or adverse reaction to NSAIDs, opioids, or acetaminophen\n* 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\n* Pregnant or breastfeeding patients\n* 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)\n* Patients unable to read or understand the informed consent form\n* Patients weighing less than 45 kg\n* Patients scheduled for transfer to the intensive care unit instead of a general ward after surgery (ICU preparation)\n* Patients scheduled for emergency surgery","ALL","20 Years","80 Years",{"count":50,"type":51},160,"ESTIMATED","INTERVENTIONAL",[54],"PHASE4","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.\n\nObjective: 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.\n\nHypothesis: 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).\n\nStudy 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.",[57,58,59],"Stomach Neoplasms","Pain","Postoperative",[61],"Gastrectomy","NOT_YET_RECRUITING","2026-06-29",{"date":65,"type":66},"2026-07-07","ACTUAL",{"date":68,"type":51},"2026-07-01",{"date":70,"type":51},"2028-12-31",{"name":5,"class":6}]