Determining the Effect of an "Alternate Recovery Protocol" Versus Current Standard of Care After Cesarean Section
Stopped early · Phase 3
Conditions studied: Pregnancy Related, Narcotic Use
In brief
This randomized controlled trial will compare two different approaches to patient recovery after cesarean section: the current standard of care versus an alternate management protocol. The goal of this study is to investigate whether an "alternate management" protocol after cesarean sections will yield the same results as alternate management in other surgical fields, including decreased narcotic consumption and quicker return of bowel function, without compromising patient morbidity or satisfaction. The investigators will assess postoperative narcotic consumption as the primary outcome. Secondary outcomes will be return of bowel function, length of hospital stay, pain control, patient satisfaction, post-operative complications, and overall morbidity and mortality. Hypothesis: Initiating the alternate management protocol for cesarean sections will decrease narcotic consumption and hasten return of bowel function, without compromising patient satisfaction, level of pain control, or post-operative morbidity.
Key facts
- Study ID
- NCT03330119
- Run by
- Brest, Norman A., M.D.
- People needed
- 1494
- Starts
- 2017-10-04
- Expected to finish
- 2018-06-20
- Last updated by the study team
- 2021-03-02
Who can join
Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Scheduled to undergo a cesarean section
You may not qualify if…
- Existing diagnosis of chronic pain
- Need to undergo a vertical skin incision
- AST > 50; ALT > 70
- Platelets below 80,000 on admission
- Need to undergo general anesthesia
- Tubal ligation at time of Cesarean section
- Prior or known allergy to any of the medications being utilized in this study
Where it is running
- Lankenau Medical Center — Wynnewood, Pennsylvania, United States
Full record on ClinicalTrials.gov
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