drugset / Trial / NCT03330119

Determining the Effect of an "Alternate Recovery Protocol" Versus Current Standard of Care After Cesarean Section

NCT03330119

Phase 3 Terminated 1494 enrolled Brest, Norman A., M.D.
RandomizedParallel-groupOpen-labelSupportive care

Summary

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.

Timeline

Start
2017-10-04
Primary completion
2018-06-20
Completion
2018-06-20

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Acetaminophen Small molecule 975 mg Intravenous
Subject Gabapentin Small molecule 600 mg Oral
Subject Ibuprofen Small molecule 600 mg Oral
Subject Ondansetron Other / unclassified 8 mg Intravenous
Comparator Hydromorphone Other / unclassified
Background Ketorolac Other / unclassified 30 mg Intravenous
Comparator Oxycodone/acetaminophen Unknown