Post-cesarean Analgesia: Comparing Effectiveness of Staggered v. Simultaneous Therapies (NCT07102641) | Clinical Trial Compass
RecruitingPhase 4
Post-cesarean Analgesia: Comparing Effectiveness of Staggered v. Simultaneous Therapies
United States825 participantsStarted 2025-08-26
Plain-language 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.
Who can participate
Age range
16 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Postpartum pain control
Timeframe: 48 (+/- 2) hours postpartum
2
Opioid consumption
Timeframe: Postpartum Admission (From time of surgery to hospital discharge; typically 2-5 days)