None listed
Conditions
Interventions
Drug : 1. POPCORN2-1 (Experimental group)
1) Medications: acetaminophen, ibuprofen
2) Dosage per administration:
- For patients weighing 50 kg or more: acetaminophen 1000 mg and ibuprofen 300 mg
- For
Sponsors
Seoul National University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) American Society of Anesthesiologists (ASA) Physical Status classification I–II 2) Patients requiring a midline laparotomy with an incision above the umbilicus (including those undergoing video-assisted thoracoscopic surgery, if applicable) 3) Patients with normal hepatic, renal, respiratory, and coagulation function 4) Patients who have received a full explanation of the study and have provided written informed consent voluntarily
Exclusion criteria
Exclusion criteria: 1) Patients with local or systemic pain unrelated to the midline incision prior to surgery 2) Patients scheduled for minimally invasive surgery 3) Patients requiring a Pfannenstiel incision or an incision below the umbilicus 4) Patients undergoing other concurrent surgical procedures, except for video-assisted thoracoscopic surgery 5) Patients with contraindications or precautions for acetaminophen use ? Severe hepatic dysfunction or renal failure, or a history of hypersensitivity reactions 6) Patients with contraindications or precautions for ibuprofen use ? Allergy to nonsteroidal anti-inflammatory drugs (NSAIDs) or aspirin, active peptic ulcer or gastrointestinal bleeding, severe heart failure, renal failure, hepatic failure, pregnancy beyond 20 weeks, or perioperative period of coronary artery bypass graft surgery 7) Patients with contraindications or precautions for tramadol use ? Hypersensitivity, severe respiratory depression, severe asthma, gastrointestinal obstruction, or concomitant use of monoamine oxidase (MAO) inhibitors 8) Patients with a history of adverse reactions to fentanyl ? Hypersensitivity, severe respiratory depression, increased intracranial pressure, concomitant use of MAO inhibitors, or severe myasthenia gravis 9) Patients expected to develop adverse reactions to PCA (e.g., allergies) 10) Pregnant or breastfeeding women 11) Patients with comorbidities (e.g., hypertension, diabetes mellitus) that are not adequately controlled 12) Patients with severe hepatic, renal, cardiac, or respiratory disease 13) Patients with a history of active peptic ulcer or gastrointestinal bleeding 14) Patients taking concomitant medications with a risk of serious drug–drug interactions with the study drugs (e.g., anticoagulants, antiplatelet agents, other NSAIDs, or aspirin) 15) Patients with cognitive impairment or communication difficulties that prevent understanding or compliance with the study procedures, or who are unable to provide informed consent independently 16) Patients who have not provided written informed consent to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Numeric rating scale score at 24 hours after surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Length of hospital stay after surgery;Numeric rating scale (NRS) scores up to 72 hours after surgery;Quality of Recovery-15K results at 24 hours after surgery;Discontinuation of patient-controlled analgesia within 72 hours after surgery;Duration of patient-controlled analgesia (PCA) use within 72 hours after surgery;Amount of rescue analgesics used within 72 hours after surgery;Safety assessment of the investigational drug or placebo;Numeric rating scale (NRS) score at one month after surgery;Types of complications within one month after surgery;EQ-5D-5L assessment at one month after surgery;Evaluation of 15-hydroxyprostaglandin dehydrogenase expression in peritoneal tissue | — |
Countries
Korea, Republic of
Contacts
Public ContactHee Seung Kim
Seoul National University Hospital
Outcome results
None listed