Actively Recruiting
Efficacy of Intravenous Acetaminophen Alone Versus Combination of Acetaminophen/Ibuprofen (Maxigesic®IV) in Multimodal Analgesia After Cesarean Section: a Randomized Controlled Trial
Led by Seoul National University Hospital · Updated on 2025-06-04
84
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are comparing the pain relief effects of intravenous acetaminophen alone versus a combination of acetaminophen and ibuprofen (Maxigesic®IV) for managing pain after cesarean section. The study focuses on evaluating these treatments as part of multimodal pain management following surgery in women undergoing elective cesarean delivery. Participants will receive either 1 gram of acetaminophen alone or a combination of 1 gram acetaminophen and 300 mg ibuprofen administered intravenously during skin closure at the end of the operation. The same dose is repeated 6 hours after the first administration. This is a randomized, triple-blind trial designed to assess and compare these two pain management approaches. During the study, researchers will assess pain levels at multiple time points after surgery, including 4, 8, 12, 24, and 48 hours, using a numeric rating scale. They will also measure patient-controlled analgesia use and rescue analgesia needs within 24 and 48 hours post-surgery. Other evaluations include wound-related complications, operation and anesthesia duration, and drug effects during and after surgery. The main outcome is the quality of recovery score 24 hours after surgery, with close monitoring throughout the hospital stay.
CONDITIONS
Brief Title
Efficacy of Acetaminophen Alone Versus Combination of Acetaminophen/Ibuprofen After Cesarean Section
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients scheduled for elective cesarean section
- Gestational age greater than 37+0 weeks
- Female patients aged 19 years or older
You will not qualify if you...
- Emergency cesarean section
- Multiple pregnancy (e.g., twins, triplets)
- Body weight less than 50 kg
- Preeclampsia
- History of hypersensitivity to acetaminophen or ibuprofen
- History of upper gastrointestinal tract bleeding or gastric ulcer
- Underlying liver disease
- Underlying kidney disease or GFR less than 90 mL/min/1.73m2
- Heart failure or severe hypertension
- History of asthma
- Chronic use of barbital or tricyclic antidepressants
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From the time of surgery up to 6 hours after the first administration
Participants receive intravenous acetaminophen alone or a combination of acetaminophen and ibuprofen during cesarean section and again 6 hours later to manage pain.
1 surgical procedure visit and 1 follow-up dosing visit
Duration - Up to 5 days after surgery
Participants are monitored for pain relief and wound-related complications up to 5 days after surgery.
Approximately 3 visits during hospital stay
Trial Site Locations
Total: 1 location
1
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
Research Team
H
Hansol Kim, MD
J
Junghwa Seo, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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