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NCT Number: NCT06479122

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

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.

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Key information

Conditions

Cesarean Section Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Pain Signs and Symptoms

Age range

19 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acetaminophen

Drug

1g acetaminophen is administered during skin closure (end of operation).

Other names: Acetaminophen #1

Acetaminophen/Ibuprofen

Drug

A mixture of 1g acetaminophen and 300 mg ibuprofen (Maxigesic®IV) is administered during skin closure (end of operation)

Other names: Acetaminophen/Ibuprofen #1

Primary outcomes

  1. Obstetric QoR-11K score 24 hours after end of surgery

    Time frame: 24 hours after end of surgery

    Minimum 0, poor recovery; maximum 110, good recovery

Secondary outcomes

  1. Numeric rating scale pain score (0-10) 4 hours after end of surgery

    Time frame: 4 hours after end of surgery

    0, no pain; 10, worst pain imaginable

  2. Numeric rating scale pain score (0-10) 8 hours after end of surgery

    Time frame: 8 hours after end of surgery

    0, no pain; 10, worst pain imaginable

  3. Numeric rating scale pain score (0-10) 12 hours after end of surgery

    Time frame: 12 hours after end of surgery

    0, no pain; 10, worst pain imaginable

  4. Numeric rating scale pain score (0-10) 24 h after end of surgery

    Time frame: 24 h after end of surgery

  5. Numeric rating scale pain score (0-10) 48 hours after end of surgery

    Time frame: 48 hours after end of surgery

    0, no pain; 10, worst pain imaginable

  6. Use of patient-controlled analgesia (FTN, micrograms) during the first 24 hours after end of surgery

    Time frame: 24 h after end of surgery

  7. Use of patient-controlled analgesia (FTN, micrograms) during the first 48 hours after end of surgery

    Time frame: 48 h after end of surgery

  8. Use of rescue analgesia during the first 24 hours after end of surgery

    Time frame: 24 h after end of surgery

  9. Use of rescue analgesia during the first 48 hours after end of surgery

    Time frame: 48 h after end of surgery

  10. Wound-related complications during hospital stay, up to 5 days

    Time frame: From end of surgery to patient discharge, up to 5 days

  11. Operation time

    Time frame: Duration of operation

  12. Anesthesia time

    Time frame: Duration of anesthesia

  13. Injection level of intrathecal drug

    Time frame: After arrival at the operating room

  14. Dosage of intrathecal drug (mg, bupivacaine)

    Time frame: After arrival at the operating room

  15. Sensory blockade level by time point

    Time frame: 0, 5, 10 minutes after intrathecal injection and at the end of operation

Study contacts

Contact information is provided by the study sponsor or research team.

Hansol Kim, MD

CONTACT

[email protected]

+82-10-3160-1548

Junghwa Seo, MD, PhD

CONTACT

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 28, 2024
Registry last updated
Jun 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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