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

NCT ID: NCT07102641

Last Updated: 2025-09-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 825 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-26
• Study Completion Date: 2027-12-31

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.

Detailed Description

Cesarean delivery is a commonly performed surgical procedure. The rate of cesarean delivery (CD) is increasing in the US; cesarean accounted for 32% of all births in 2022. Parents who deliver via CD experience more pain than those who have a vaginal birth. Uncontrolled postpartum pain can be associated with an increased risk of physical complications including venous thrombosis, atelectasis, pneumonia as well as increased psychological distress. Poor postpartum pain control can also hinder infant-parental bonding and impact breastfeeding initiation or continuation.

Multiple strategies for post-operative pain management exist including opioid and non-opioid medications. Multimodal non-opioid medications are preferred as first-line therapies due to the short- and long-term risks associated with opioid pain medication. Acetaminophen and ibuprofen are most commonly utilized in the US. A meta-analysis of 21 studies enrolling 1909 post-operative patients examined the efficacy of NSAIDs and parecetamol in combination compared to each drug alone and found a significant reduction in pain intensity for combination therapy compared to each drug alone.

Both acetaminophen and ibuprofen can be given every 6 hours. Practices differ, however, on administering these medications at the same time or in a staggered fashion. To date, there are no trials comparing these different dosing schedules for post-cesarean delivery pain control.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Staggered

Medications administered 3H apart (Staggered)

Group Type: ACTIVE_COMPARATOR

Acetaminophen

Intervention Type: DRUG

Acetaminophen 1000 mg q6H

NSAID (Ketorolac/Ibuprofen)

Intervention Type: DRUG

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

Simultaneous

Medications administered at the same time. (Simultaneous)

Group Type: ACTIVE_COMPARATOR

Acetaminophen

Intervention Type: DRUG

Acetaminophen 1000 mg q6H

NSAID (Ketorolac/Ibuprofen)

Intervention Type: DRUG

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

Interventions

Acetaminophen

Acetaminophen 1000 mg q6H

Intervention Type: DRUG

NSAID (Ketorolac/Ibuprofen)

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 16 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Thomas Jefferson University

OTHER

Sponsor Role: lead

Responsible Party

Whitney Bender

Assistant Professor, Department of Obstetrics and Gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Whitney Bender, MD

Role: CONTACT

whitney.bender@jefferson.edu

434-294-8416

Brandy Firman

Role: CONTACT

brandy.firman@jefferson.edu

215-586-1656

Facility Contacts

Whitney Bender

Role: primary

whitney.bender@jefferson.edu

494-294-8416

Brandy Firman

Role: backup

brandy.firman@jefferson.edu

215-586-1656

Other Identifiers

iRISID-2024-1669

Identifier Type: -

Identifier Source: org_study_id