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

Efficacy of Intravenous Acetaminophen Alone Versus Combination of Acetaminophen/Ibuprofen (Maxigesic®IV) in Multimodal Analgesia After Cesarean Section: a Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Pain; Cesarean Section
• Intervention / Treatment: Drug: Acetaminophen; Drug: Acetaminophen; Drug: Acetaminophen/Ibuprofen; Drug: Acetaminophen/Ibuprofen

• Study Type: Interventional
• Enrollment (Estimated): 84
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Hansol Kim, MD; Phone Number: +82-10-3160-1548; Email: hansolfrkr@gmail.com
• Study Contact Backup: Name: Junghwa Seo, MD, PhD

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Recruiting
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Acetaminophen	Drug: Acetaminophen; 1g acetaminophen is administered during skin closure (end of operation).; Other Names: Acetaminophen #1; Drug: Acetaminophen; 1g acetaminophen is administered 6 hours after the first administration.; Other Names: Acetaminophen #2
Experimental: Acetaminophen/Ibuprofen	Drug: Acetaminophen/Ibuprofen; A mixture of 1g acetaminophen and 300 mg ibuprofen (Maxigesic®IV) is administered during skin closure (end of operation); Other Names: Acetaminophen/Ibuprofen #1; Drug: Acetaminophen/Ibuprofen; A mixture of 1g acetaminophen and 300 mg ibuprofen (Maxigesic®IV) is administered 6 hours after the first administration.; Other Names: Acetaminophen/Ibuprofen #2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Obstetric QoR-11K score 24 hours after end of surgery	Minimum 0, poor recovery; maximum 110, good recovery	24 hours after end of surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numeric rating scale pain score (0-10) 4 hours after end of surgery	0, no pain; 10, worst pain imaginable	4 hours after end of surgery
Numeric rating scale pain score (0-10) 8 hours after end of surgery	0, no pain; 10, worst pain imaginable	8 hours after end of surgery
Numeric rating scale pain score (0-10) 12 hours after end of surgery	0, no pain; 10, worst pain imaginable	12 hours after end of surgery
Numeric rating scale pain score (0-10) 24 h after end of surgery		24 h after end of surgery
Numeric rating scale pain score (0-10) 48 hours after end of surgery	0, no pain; 10, worst pain imaginable	48 hours 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 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 24 hours after end of surgery		24 h after end of surgery
Use of rescue analgesia during the first 48 hours after end of surgery		48 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
Operation time		Duration of operation
Anesthesia time		Duration of anesthesia
Injection level of intrathecal drug		After arrival at the operating room
Dosage of intrathecal drug (mg, bupivacaine)		After arrival at the operating room
Sensory blockade level by time point		0, 5, 10 minutes after intrathecal injection and at the end of operation

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2024
• Primary Completion (Estimated): June 25, 2026
• Study Completion (Estimated): August 25, 2026

Study Registration Dates

• First Submitted: June 18, 2024
• First Submitted That Met QC Criteria: June 24, 2024
• First Posted (Actual): June 28, 2024

Study Record Updates

• Last Update Posted (Actual): June 4, 2025
• Last Update Submitted That Met QC Criteria: June 1, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pain, Postoperative; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Antirheumatic Agents; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Antipyretics; Anti-Inflammatory Agents, Non-Steroidal; Cyclooxygenase Inhibitors; Acetaminophen; Ibuprofen
• Other Study ID Numbers: 2405-052-1535

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No