drugset / Trial / NCT04612920

Towards Enhanced Recovery After Cesarean

NCT04612920

Phase 0 Completed 33 enrolled University of Oklahoma
RandomizedParallel-groupOpen-labelHealth-services research

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.

Timeline

Start
2020-12-12
Primary completion
2023-03-08
Completion
2023-03-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Acetaminophen Small molecule 1000 mg
Subject Ibuprofen Small molecule 800 mg
Background Oxycodone Other / unclassified 5 mg

Indications

No indication recorded.