RecruitingPhase 4NCT07102641

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

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


Sponsor

Thomas Jefferson University

Enrollment

825 participants

Start Date

Aug 26, 2025

Study Type

INTERVENTIONAL

Summary

Cesarean delivery is a commonly performed surgical procedure associated with worse postpartum pain when compared to vaginal birth. Uncontrolled postpartum pain is associated with increased neonatal and maternal risks. Multimodal non-opioid pain medications, including acetaminophen and non-steroidal anti-inflammatory drugs (NSAIDs) are the preferred first-line therapies. There is no standard practice, however, on best dosing schedules (ie staggered or different time v. simultaneous or same time). This protocol describes a randomized clinical trial aimed to determine whether staggered dosing of acetaminophen and NSAIDs in superior to simultaneous dosing in controlling post-cesarean pain.


Eligibility

Sex: FEMALEMin Age: 16 Years

Inclusion Criteria3

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

Exclusion Criteria7

  • 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

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Interventions

DRUGAcetaminophen

Acetaminophen 1000 mg q6H

DRUGNSAID (Ketorolac/Ibuprofen)

NSAID (ketorolac 30 mg q6H for first 24 hours post-op followed by ibuprofen 600 mg q6H)


Locations(1)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

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NCT07102641