Clinical trial NCT06479122: Efficacy of Acetaminophen Alone Versus Combination of Acetaminophen/Ibuprofen After Cesarean Section
Official title: Efficacy of Intravenous Acetaminophen Alone Versus Combination of Acetaminophen/Ibuprofen (Maxigesic®IV) in Multimodal Analgesia After Cesarean Section: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Cesarean Section
Postoperative Pain
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2024-06-28
Enrollment: 84
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Obstetric QoR-11K score 24 hours after end of surgery
timeFrame: 24 hours after end of surgery
Secondary outcomes:
measure: Numeric rating scale pain score (0-10) 4 hours after end of surgery
timeFrame: 4 hours after end of surgery
measure: Numeric rating scale pain score (0-10) 8 hours after end of surgery
timeFrame: 8 hours after end of surgery
measure: Numeric rating scale pain score (0-10) 12 hours after end of surgery
timeFrame: 12 hours after end of surgery
measure: Numeric rating scale pain score (0-10) 24 h after end of surgery
timeFrame: 24 h after end of surgery
measure: Numeric rating scale pain score (0-10) 48 hours after end of surgery
timeFrame: 48 hours after end of surgery
measure: Use of patient-controlled analgesia (FTN, micrograms) during the first 24 hours after end of surgery
timeFrame: 24 h after end of surgery
measure: Use of patient-controlled analgesia (FTN, micrograms) during the first 48 hours after end of surgery
timeFrame: 48 h after end of surgery
measure: Use of rescue analgesia during the first 24 hours after end of surgery
timeFrame: 24 h after end of surgery
measure: Use of rescue analgesia during the first 48 hours after end of surgery
timeFrame: 48 h after end of surgery
measure: Wound-related complications during hospital stay, up to 5 days
timeFrame: From end of surgery to patient discharge, up to 5 days
measure: Operation time
timeFrame: Duration of operation
measure: Anesthesia time
timeFrame: Duration of anesthesia
measure: Injection level of intrathecal drug
timeFrame: After arrival at the operating room
measure: Dosage of intrathecal drug (mg, bupivacaine)
timeFrame: After arrival at the operating room
measure: Sensory blockade level by time point
timeFrame: 0, 5, 10 minutes after intrathecal injection and at the end of operation
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References: