NCT07102641 Post-cesarean Analgesia: Comparing Effectiveness of Staggered v. Simultaneous Therapies
| NCT ID | NCT07102641 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Thomas Jefferson University |
| Condition | Cesarean Delivery |
| Study Type | INTERVENTIONAL |
| Enrollment | 825 participants |
| Start Date | 2025-08-26 |
| Primary Completion | 2027-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 825 participants in total. It began in 2025-08-26 with a primary completion date of 2027-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07102641 clinical trial?
This trial is open to female participants only, aged 16 Years or older, studying Cesarean Delivery. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07102641 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07102641 currently recruiting?
Yes, NCT07102641 is actively recruiting participants. Contact the research team at whitney.bender@jefferson.edu for enrollment information.
Where is the NCT07102641 trial being conducted?
This trial is being conducted at Philadelphia, United States.
Who is sponsoring the NCT07102641 clinical trial?
NCT07102641 is sponsored by Thomas Jefferson University. The trial plans to enroll 825 participants.