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

NCT07102641 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 825

Last updated 2025-09-03

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

Acetaminophen

Acetaminophen 1000 mg q6H

DRUG

NSAID (Ketorolac/Ibuprofen)

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

Sponsors & Collaborators

  • Thomas Jefferson University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-26
Primary Completion
2027-08-31
Completion
2027-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07102641 on ClinicalTrials.gov