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Recruiting NCT06479122

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

Phase IV Interventional Cesarean Section Postoperative Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Acetaminophen, Acetaminophen/Ibuprofen, Acetaminophen, Acetaminophen/Ibuprofen.
Who it may be relevant to
Registry conditions: Cesarean Section, Postoperative Pain. Basic parameters: from 19 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Drug Acetaminophen
    1g acetaminophen is administered during skin closure (end of operation).
  • Drug Acetaminophen/Ibuprofen
    A mixture of 1g acetaminophen and 300 mg ibuprofen (Maxigesic®IV) is administered during skin closure (end of operation)
  • Drug Acetaminophen
    1g acetaminophen is administered 6 hours after the first administration.
  • Drug Acetaminophen/Ibuprofen
    A mixture of 1g acetaminophen and 300 mg ibuprofen (Maxigesic®IV) is administered 6 hours after the first administration.

Primary outcome measures

  • Obstetric QoR-11K score 24 hours after end of surgery [Time frame: 24 hours after end of surgery]
Secondary outcome measures (12)
  • Numeric rating scale pain score (0-10) 4 hours after end of surgery [Time frame: 4 hours after end of surgery]
  • Numeric rating scale pain score (0-10) 8 hours after end of surgery [Time frame: 8 hours after end of surgery]
  • Numeric rating scale pain score (0-10) 12 hours after end of surgery [Time frame: 12 hours after end of surgery]
  • Numeric rating scale pain score (0-10) 24 h after end of surgery [Time frame: 24 h after end of surgery]
  • Numeric rating scale pain score (0-10) 48 hours after end of surgery [Time frame: 48 hours after end of surgery]
  • Use of patient-controlled analgesia (FTN, micrograms) during the first 24 hours after end of surgery [Time frame: 24 h after end of surgery]
  • Use of patient-controlled analgesia (FTN, micrograms) during the first 48 hours after end of surgery [Time frame: 48 h after end of surgery]
  • Use of rescue analgesia during the first 24 hours after end of surgery [Time frame: 24 h after end of surgery]
  • Use of rescue analgesia during the first 48 hours after end of surgery [Time frame: 48 h after end of surgery]
  • Wound-related complications during hospital stay, up to 5 days [Time frame: From end of surgery to patient discharge, up to 5 days]
  • Operation time [Time frame: Duration of operation]
  • Anesthesia time [Time frame: Duration of anesthesia]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

South Korea · 1 center
  • Seoul National University Hospital — Seoul

Identifiers

NCT: NCT06479122 · 2405-052-1535

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗