None listed
Conditions
Interventions
Drug : 1. POPCORN3-1 (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) Participation in the PIPAC-OVPAC-1/2a study (cohort 1) 3) Normal hepatic, renal, respiratory, and coagulation function 4) Provision of voluntary written informed consent after receiving sufficient information about the study
Exclusion criteria
Exclusion criteria: 1) Patients with local or systemic pain outside the abdomen prior to surgery 2) Patients who require concurrent surgical procedures other than PIPAC 3) Patients with abdominal pain caused by bowel obstruction, tumor, or organ enlargement 4) Patients with contraindications or precautions for acetaminophen ? Severe hepatic dysfunction or renal failure, or a history of hypersensitivity 5) Patients with contraindications or precautions for ibuprofen ? Allergy to nonsteroidal anti-inflammatory drugs (NSAIDs) or aspirin, active peptic ulcer or gastrointestinal bleeding, severe heart, renal, or hepatic failure, pregnancy beyond 20 weeks, perioperative period of coronary artery bypass graft surgery, etc. 6) Patients with contraindications or precautions for tramadol ? Hypersensitivity, severe respiratory depression, severe asthma, gastrointestinal obstruction, or concomitant use of monoamine oxidase (MAO) inhibitors 7) 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 8) Patients in whom adverse reactions to PCA (e.g., allergy) are anticipated 9) Pregnant or breastfeeding women 10) Patients whose comorbidities (e.g., hypertension, diabetes mellitus) are not adequately controlled 11) Patients with severe hepatic, renal, cardiac, or respiratory disease 12) Patients with a history of active peptic ulcer or gastrointestinal bleeding 13) Patients taking concomitant medications that pose a risk of serious drug–drug interactions with the study drugs (e.g., anticoagulants, antiplatelet agents, other NSAIDs, or aspirin) 14) Patients with cognitive impairment or communication difficulties who are unable to understand or comply with the study procedures, or who are unable to provide informed consent independently 15) 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 48 hours after surgery;Quality of Recovery-15K results at 24 hours after surgery;Discontinuation of patient-controlled analgesia within 48 hours after surgery;Duration of patient-controlled analgesia (PCA) use within 48 hours after surgery;Amount of rescue analgesics used within 48 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