Efficacy of Acetaminophen Alone Versus Combination of Acetaminophen/Ibuprofen After Cesarean Section

Phase 4

Not yet recruiting

• Conditions: Cesarean Section; Postoperative Pain
• Interventions: Drug: Acetaminophen; Drug: Acetaminophen/Ibuprofen

• Registration Number: NCT06479122
• Lead Sponsor: Seoul National University Hospital

Brief Summary

The investigators aim to compare the analgesic efficacy of intravenous acetaminophen alone versus combination of acetaminophen/ibuprofen (Maxigesic®IV) in multimodal analgesia after cesarean section.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-06-18
• Study First Submitted QC: 2024-06-24
• Study First Posted: 2024-06-28
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-21
• Last Update Posted: 2024-07-23
• Study Start: 2024-08-25
• Primary Completion: 2025-06-25
• Study Completion: 2025-08-25

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 84

Inclusion Criteria

• Patients scheduled for elective cesarean section
• Gestational age > 37+0 weeks

Exclusion Criteria

• Emergency cesarean section
• Multiple pregnancy (e.g. twins, triplets)
• Body weight < 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 < 90 mL/min/1.73m2
• Heart failure or severe hypertension
• History of asthma
• Chronic use of barbital or tricyclic antidepressants

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acetaminophen	Acetaminophen	-
Acetaminophen/Ibuprofen	Acetaminophen/Ibuprofen	-

Primary Outcome Measures

Name	Time	Method
Obstetric QoR-11K score 24 hours after end of surgery	24 hours after end of surgery	Minimum 0, poor recovery; maximum 110, good recovery

Secondary Outcome Measures

Name	Time	Method
Operation time	Duration of operation
Injection level of intrathecal drug	After arrival at the operating room
Dosage of intrathecal drug (mg, bupivacaine)	After arrival at the operating room
Numeric rating scale pain score (0-10) 4 hours after end of surgery	4 hours after end of surgery	0, no pain; 10, worst pain imaginable
Numeric rating scale pain score (0-10) 8 hours after end of surgery	8 hours after end of surgery	0, no pain; 10, worst pain imaginable
Numeric rating scale pain score (0-10) 48 hours after end of surgery	48 hours after end of surgery	0, no pain; 10, worst pain imaginable
Use of patient-controlled analgesia (FTN, micrograms) during the first 48 hours after end of surgery	48 h after end of surgery
Use of rescue analgesia during the first 48 hours after end of surgery	48 h after end of surgery
Sensory blockade level by time point	0, 5, 10 minutes after intrathecal injection and at the end of operation
Numeric rating scale pain score (0-10) 12 hours after end of surgery	12 hours after end of surgery	0, no pain; 10, worst pain imaginable
Numeric rating scale pain score (0-10) 24 h after end of surgery	24 h after end of surgery
Use of patient-controlled analgesia (FTN, micrograms) during the first 24 hours after end of surgery	24 h after end of surgery
Use of rescue analgesia during the first 24 hours after end of surgery	24 h after end of surgery
Wound-related complications during hospital stay, up to 5 days	From end of surgery to patient discharge, up to 5 days
Anesthesia time	Duration of anesthesia