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NCT04612920 · ClinicalTrials.gov registry record · Early Phase 1
Towards Enhanced Recovery After Cesarean
A Early Phase 1 study, sponsored by University of Oklahoma.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 33
- Enrollment target
NCT04612920 is a Early Phase 1 study that has completed, run by University of Oklahoma. The registered enrollment target is 33 participants.
The verdict
NCT04612920, a Early Phase 1 study, has completed, sponsored by University of Oklahoma.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 33 participants
- Enrollment target
Study Summary
One in 300 women will become persistent opioid users after cesarean delivery (1). Cesarean delivery is the most common surgical procedure in the United States, representing 31.9% of the 3,788,235 deliveries in 2018 (2). Patients have to cope with the pain and challenges of post-operative care while adjusting to motherhood and completing activities of daily living. Often when they return home, they are also tasked with other domestic roles which compounds the challenge of this post-operative period. With a potential impact just in the US on 1.2 million mothers each year, optimizing post-operative pain management in order to reduce the risk of persistent opioid use represents an urgent unmet public health goal. To this end, there are national efforts to reduce the cesarean rate and optimize post-cesarean pain management (3,4). The majority of efforts in the last few years have focused on home-going medications and alterations in prescription practices. Recent recommendations from the Enhanced Recovery After Surgery Society indicate that patients should receive multi-modal analgesia on a regular basis, along with early post-delivery mobilization (3). However, the efficacy of scheduled non-steroidal anti-inflammatory medications (NSAID) along with acetaminophen in the immediate post-operative period and after going home have not been systematically studied in the cesarean population. We hypothesize that patients who receive scheduled medications in the post-operative period are less likely to require opioids for pain relief both in the hospital and after they return home.
Interventions
- DRUG Ibuprofen, acetaminophen, oxycodone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2020-12-12 |
| Est. Completion | 2023-03-08 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04612920
The ClinicalTrials.gov registry entry for NCT04612920 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 33 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Oklahoma, which has 358 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Ibuprofen, acetaminophen, oxycodone is the first listed.
NCT04612920 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04612920 about?
NCT04612920 is a clinical study titled "Towards Enhanced Recovery After Cesarean". One in 300 women will become persistent opioid users after cesarean delivery (1). Cesarean delivery is the most common surgical procedure in the United States, representing 31.9% of the 3,788,235 deliveries in 2018 (2). Patients have to cope with the pain and challenges of post-operative care while ...
What is the current status of trial NCT04612920?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 33 participants. The study started on 2020-12-12. Estimated completion is 2023-03-08.
What interventions are being tested in trial NCT04612920?
The interventions under investigation include: Ibuprofen, acetaminophen, oxycodone (DRUG).
Who is sponsoring clinical trial NCT04612920?
This trial is sponsored by University of Oklahoma, which has 358 total clinical trials registered on ClinicalTrials.gov.
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