Actively Recruiting
Post-cesarean Analgesia: Comparing Effectiveness of Staggered versus Simultaneous Acetaminophen and NSAID Therapies
Led by Thomas Jefferson University · Updated on 2025-09-03
825
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Cesarean delivery is a common surgical procedure with increasing rates in the US, accounting for 32% of all births in 2022. Parents who deliver by cesarean often experience more postpartum pain compared to vaginal births. Uncontrolled postpartum pain can lead to physical complications like venous thrombosis and pneumonia, as well as psychological distress, affecting infant-parent bonding and breastfeeding. This trial evaluates whether taking acetaminophen and NSAIDs in a staggered schedule is better than taking them simultaneously to control post-cesarean pain. The study compares two approaches of administering non-opioid pain medicines: one group takes acetaminophen and NSAIDs 3 hours apart (staggered), while the other takes both at the same time (simultaneous). Acetaminophen is given at 1000 mg every 6 hours, and NSAIDs include ketorolac 30 mg every 6 hours for the first 24 hours followed by ibuprofen 600 mg every 6 hours. The trial randomly assigns participants to these two groups and monitors pain control after cesarean delivery. Participants are mothers delivering by cesarean under regional anesthesia with singleton pregnancies at 34 or more weeks gestation. Researchers assess postpartum pain at multiple time points up to 48 hours after delivery and track opioid use from surgery until hospital discharge. Other measures include length of hospital stay, infant feeding at discharge, patient satisfaction, and opioid use at home up to two weeks post-surgery. The study aims to improve pain management during the critical postpartum period while minimizing opioid exposure.
CONDITIONS
Brief Title
Post-cesarean Analgesia: Comparing Effectiveness of Staggered v. Simultaneous Therapies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant with singleton pregnancy at 34 weeks gestation or more
- Planning delivery by cesarean section under regional anesthesia
You will not qualify if you...
- Allergy or contraindication to acetaminophen or NSAIDs
- Current or history of opioid use or misuse
- Intrauterine fetal demise
- Major congenital anomaly
- Conversion to general anesthesia during surgery or planned general anesthesia
- Mid-line vertical skin incision
- Receipt of intraoperative local analgesia like TAP block or wound infiltration
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From time of surgery to hospital discharge (typically 2 to 5 days)
Participants receive acetaminophen and NSAID medications administered either 3 hours apart (staggered) or at the same time (simultaneous) for post-cesarean pain control.
Daily visits during hospital stay (typically 2 to 5 days)
Duration - Up to 14 days post-operation
Participants are monitored for opioid use and pain control after hospital discharge, including opioid prescription and home opioid use.
1 visit at hospital discharge and 1 follow-up visit around post-operative days 10 to 14
Trial Site Locations
Total: 1 location
1
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
Research Team
W
Whitney Bender, MD
B
Brandy Firman
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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