NCT07102641

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
825

participants targeted

Target at P75+ for phase_4

Timeline
20mo left

Started Aug 2025

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress31%
Aug 2025Dec 2027

First Submitted

Initial submission to the registry

July 25, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 4, 2025

Completed
22 days until next milestone

Study Start

First participant enrolled

August 26, 2025

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

September 3, 2025

Status Verified

September 1, 2025

Enrollment Period

1.9 years

First QC Date

July 25, 2025

Last Update Submit

September 2, 2025

Conditions

Cesarean DeliveryPostpartum ComfortPostpartum PainPost-operative PainNSAIDsAcetaminophen (D000082)

Outcome Measures

Primary Outcomes (2)

  • Postpartum pain control

    Visual analog pain score (VAS) with movement. Scale ranges from 0-10 with 0 indicating no pain and 10 indicating worst possible pain

    48 (+/- 2) hours postpartum

  • Opioid consumption

    Opioid consumption (in total morphine milligram equivalents (MME))

    Postpartum Admission (From time of surgery to hospital discharge; typically 2-5 days)

Secondary Outcomes (10)

  • Postpartum pain at 6 hours

    6 hours (+/- 1 hour) post-op

  • Postpartum pain at 12 hours

    12 hours (+/-2 hours) post-op

  • Postpartum pain at 24 hours

    24 hours (+/-2 hours) post-op

  • Postpartum pain at 48 hours

    48 hours (+/- 2 hours) post-op.

  • Adequate pain control

    by 48 hours (+/-2 hours) post-op

  • +5 more secondary outcomes

Study Arms (2)

Staggered

ACTIVE COMPARATOR

Medications administered 3H apart (Staggered)

Drug: AcetaminophenDrug: NSAID (Ketorolac/Ibuprofen)

Simultaneous

ACTIVE COMPARATOR

Medications administered at the same time. (Simultaneous)

Drug: AcetaminophenDrug: NSAID (Ketorolac/Ibuprofen)

Interventions

AcetaminophenDRUG

Acetaminophen 1000 mg q6H

SimultaneousStaggered
NSAID (Ketorolac/Ibuprofen)DRUG

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

SimultaneousStaggered

Eligibility Criteria

Age16 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

AcetaminophenAnti-Inflammatory Agents, Non-SteroidalKetorolacIbuprofen

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesAnalgesics, Non-NarcoticAnalgesicsSensory System AgentsPeripheral Nervous System AgentsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesAnti-Inflammatory AgentsTherapeutic UsesAntirheumatic AgentsIndomethacinIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPhenylpropionatesAcids, CarbocyclicCarboxylic Acids

Central Study Contacts

Whitney Bender, MD

CONTACT

434-294-8416whitney.bender@jefferson.edu

Brandy Firman

CONTACT

215-586-1656brandy.firman@jefferson.edu

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Department of Obstetrics and Gynecology

Study Record Dates

First Submitted

July 25, 2025

First Posted

August 4, 2025

Study Start

August 26, 2025

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

September 3, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)