Staggered versus simultaneous acetaminophen and NSAID dosing after cesarean delivery

PACESS: Post-cesarean Analgesia: Comparing Effectiveness of Staggered v. Simultaneous Therapies

We will see if taking acetaminophen and an NSAID at different times versus at the same time reduces pain after a cesarean delivery.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 825 (estimated)
• Ages: 16 Years and up
• Sex: Female
• Sponsor: Thomas Jefferson University (other)
• Locations: 1 site (Philadelphia, Pennsylvania)
• Trial ID: NCT07102641 on ClinicalTrials.gov

What this trial studies

This randomized Phase 4 trial compares two non-opioid dosing schedules—staggered versus simultaneous administration of acetaminophen and an NSAID (ketorolac or ibuprofen)—for pain control after cesarean delivery. Eligible participants are people with a singleton pregnancy at ≥34 weeks who undergo cesarean section under regional anesthesia and have no contraindications to the study drugs. Participants are randomized to receive the two drugs either at the same time or offset in timing, with pain scores and opioid use tracked in the postoperative period. The primary focus is on post-cesarean pain control and related short-term maternal outcomes during the inpatient postpartum course.

Who should consider this trial

Good fit: Ideal candidates are people delivering a singleton pregnancy at ≥34 weeks by cesarean under regional anesthesia who have no contraindication to acetaminophen or NSAIDs and no current or prior opioid misuse.

Not a fit: Those with contraindications to acetaminophen or NSAIDs, conversion to or planned general anesthesia, receipt of intraoperative local analgesia (e.g., TAP block), midline vertical incisions, major fetal anomalies, intrauterine fetal demise, or a history of opioid use/misuse are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, this could lead to a simple change in dosing schedule that improves post-cesarean pain control and reduces the need for opioids, helping maternal comfort and early postpartum recovery.

How similar studies have performed: Previous studies and a meta-analysis show that combining acetaminophen and an NSAID reduces postoperative pain compared with each drug alone, but no randomized trials have directly compared staggered versus simultaneous dosing after cesarean delivery.

Eligibility criteria

Inclusion Criteria:

* \>/= 34 weeks gestation
* Singleton pregnancy
* Delivery via cesarean section under regional anesthesia

Exclusion Criteria:

* Contraindication to acetaminophen or NSAIDs
* Current or history of opioid use or misuse
* Intrauterine fetal demise
* Major congenital anomaly
* Conversion to general anesthesia intra-op or planned general anesthesia
* Mid-line vertical skin incision
* Receipt of intraoperative local analgesia such as Transversus Abdominis Plan (TAP) block or wound infiltration

Where this trial is running

Philadelphia, Pennsylvania

• Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States (RECRUITING)

Study contacts

• Study coordinator: Whitney Bender, MD

Conditions: Cesarean Delivery, Postpartum Comfort, Postpartum Pain, Post-operative Pain, NSAIDs, Acetaminophen