Cesarean Section, Postoperative Pain
Conditions
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.
Interventions
DRUGAcetaminophen
1g acetaminophen is administered during skin closure (end of operation).
A mixture of 1g acetaminophen and 300 mg ibuprofen (Maxigesic®IV) is administered during skin closure (end of operation)
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
19 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) 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 | — |
| 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 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 | — |
| 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 |
| 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 | — |
| Use of rescue analgesia during the first 48 hours after end of surgery | 48 h after end of surgery | — |
Countries
South Korea
Contacts
Primary ContactHansol Kim, MD
Backup ContactJunghwa Seo, MD, PhD
Outcome results
None listed