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

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Thomas Jefferson University
Study ID
NCT07102641
Phase
PHASE4
Status
Recruiting
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Conditions

  • Acetaminophen (D000082)
  • Cesarean Delivery
  • NSAIDs
  • Post-operative Pain
  • Postpartum Comfort
  • Postpartum Pain

Eligibility Criteria

Sex
FEMALE
Age
16 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Acetaminophen — DRUG
    Acetaminophen 1000 mg q6H
  • NSAID (Ketorolac/Ibuprofen) — DRUG
    NSAID (ketorolac 30 mg q6H for first 24 hours post-op followed by ibuprofen 600 mg q6H)

Study Details

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.

Key Dates

Start date
Aug 26, 2025
Status verified
Sep 2025
Primary completion
Aug 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
825 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Staggered
    Medications administered 3H apart (Staggered)
  • Active Comparator: Simultaneous
    Medications administered at the same time. (Simultaneous)

Primary Outcome Measure

Postpartum pain control [ Time Frame: 48 (+/- 2) hours postpartum ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Thomas Jefferson University HospitalPhiladelphiaPennsylvania19107
Whitney Bender
[email protected]
494-294-8416
Brandy Firman
[email protected]
215-586-1656
Whitney Bender, MD (PRINCIPAL_INVESTIGATOR)

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