A Phase 2 interventional study of Acetaminophen and Ibuprofen and Acetaminophen in Stomach Neoplasms, sponsored by Seoul National University Bundang Hospital. Active, not recruiting at 1 site in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-08-17.
Sponsored by Seoul National University Bundang Hospital · Phase 2, Interventional, and Treatment
This prospective, randomized, phase 4 clinical trial aims to evaluate the efficacy and safety of intravenous Maxigesic, a fixed-dose combination of acetaminophen and ibuprofen, for postoperative pain control in patients undergoing laparoscopic or robotic gastrectomy for gastric cancer. A total of 90 participants will be randomly assigned to receive either Maxigesic or intravenous acetaminophen. The primary objective is to compare postoperative pain control between the two groups using the sum of pain intensity differences over 72 hours (SPID72). Secondary outcomes include postoperative pain scores, opioid consumption, rescue analgesic use, antiemetic use, and safety outcomes.
Postoperative pain management is an important component of recovery after gastrectomy. Opioids are commonly used for the treatment of acute postoperative pain; however, opioid-related adverse effects and concerns regarding excessive opioid exposure have increased interest in multimodal analgesic strategies that combine non-opioid analgesics.
Maxigesic is an intravenous fixed-dose combination of acetaminophen 1,000 mg and ibuprofen 300 mg. This study is designed to evaluate whether perioperative administration of Maxigesic provides effective postoperative analgesia and reduces the need for opioid and rescue analgesics compared with intravenous acetaminophen alone in patients undergoing minimally invasive gastrectomy for gastric cancer.
A total of 90 adult participants scheduled to undergo laparoscopic or robotic gastrectomy will be randomly assigned in a 1:1 ratio to the Maxigesic group or the acetaminophen control group. Participants assigned to the Maxigesic group will receive intravenous Maxigesic at the initiation of anesthesia and subsequently at 6-hour intervals after surgery through 72 hours after surgery. Participants assigned to the control group will receive intravenous acetaminophen 1,000 mg at 6-hour intervals according to the postoperative analgesic protocol. Postoperative patient-controlled analgesia containing fentanyl will be available, and additional rescue analgesics may be administered as clinically indicated.
Postoperative pain intensity will be assessed using the Numeric Rating Scale (NRS) immediately after surgery and at 12, 24, 48, and 72 hours after surgery. The primary efficacy outcome is the sum of pain intensity differences over the first 72 postoperative hours (SPID72). Secondary efficacy outcomes include NRS pain scores at predefined postoperative time points, total opioid consumption during the first 48 hours, the number of rescue analgesic administrations during the first 48 hours, and the use of antiemetic medications during the first 48 hours. Safety will be evaluated through the assessment of adverse events until postoperative day 5 or hospital discharge.
3,399 studies on the registry are indexed under Stomach Neoplasms; 992 are open to participants now.
This study's enrollment of 90 is above the median of 66 across 2,499 interventional studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →Seoul National University Bundang Hospital is the lead sponsor of 376 studies on the registry; 56 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive intravenous Maxigesic (acetaminophen 1,000 mg/ibuprofen 300 mg in 100 mL) beginning at the initiation of anesthesia and subsequently at 6-hour intervals during the postoperative treatment period through 72 hours, according to the study protocol. Postoperative fentanyl-based patient-controlled analgesia (PCA) is also provided.
Drug: Acetaminophen and Ibuprofen
Participants receive intravenous acetaminophen 1,000 mg every 6 hours, four times daily, from postoperative day 0 through postoperative day 2, with a maximum daily dose of 4,000 mg. Postoperative fentanyl-based patient-controlled analgesia (PCA) is also provided.
Drug: Acetaminophen
Drug pages: Acetaminophen · Ibuprofen
Maxigesic is a fixed-dose combination containing acetaminophen 1,000 mg and ibuprofen 300 mg in 100 mL. One vial is administered intravenously over 15 minutes at the initiation of anesthesia, followed by administration at 6-hour intervals during the postoperative treatment period through 72 hours after surgery.
Also known as: Maxigesic
Acetaminophen 1,000 mg is administered intravenously over 15 minutes every 6 hours, four times daily, from postoperative day 0 through postoperative day 2. The maximum daily dose does not exceed 4,000 mg.
Sum of Pain Intensity Differences Over 72 Hours (SPID72)
Postoperative pain intensity will be assessed using the Numeric Rating Scale (NRS) immediately after surgery and at 12, 24, 48, and 72 hours after surgery. The primary outcome is the sum of pain intensity differences over the first 72 postoperative hours (SPID72).
Time frame: From immediately after surgery through 72 hours after surgery
Postoperative Pain Intensity Assessed by Numeric Rating Scale (NRS)
Postoperative pain intensity will be assessed using the Numeric Rating Scale (NRS) immediately after surgery and at 12, 24, and 48 hours after surgery.
Time frame: Immediately after surgery and at 12, 24, and 48 hours after surgery
Number of Antiemetic Administrations
The number of antiemetic administrations during the first 48 hours after surgery will be recorded and compared between the treatment groups.
Time frame: From the end of surgery through 48 hours after surgery
Total Opioid Consumption
Total opioid consumption administered through fentanyl-based patient-controlled analgesia (PCA) during the first 48 hours after surgery will be assessed.
Time frame: From the end of surgery through 48 hours after surgery
Number of Rescue Analgesic Administrations
The total number of rescue analgesic administrations, including tramadol or pethidine, during the first 48 hours after surgery will be recorded. Rescue analgesics may be administered when the NRS pain score is 4 or higher.
Time frame: From the end of surgery through 48 hours after surgery
Plan to share: No — It may be shared upon request after getting approval from our institution's IRB.
No publications or documents are linked to this record.
Started Nov 2025 (actual). Primary completion is estimated for Nov 2026, 11 months after the start.
Of 293 non-industry phase 2 interventional studies under Stomach Neoplasms, half reached primary completion within 57 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 76. This study's planned 11 months is below that.
Counting every sponsor, half of 358 studies reached it within 50 months; a quarter within 31 and three quarters within 75.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Acetaminophen · Ibuprofen
Seoul National University Bundang Hospital →