N/A
N=541
Cesarean Section Via Enhanced Recovery
Cesarean Section
Bottom Line
View on ClinicalTrials.gov: NCT03552822 ↗Enrolled (actual)
541
Serious AEs
0.0%
Results posted
Mar 2022
Primary outcome: Primary: Opioid Consumption — 60.34; 104.33 oral morphine equivalents (mg) — p=< 0.001
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- ERAS Protocol Implementation (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Alabama at Birmingham
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Opioid Consumption |
60.34; 104.33 | < 0.001 sig |
| SECONDARY Overall Average Pain Scores |
1.61; 1.90 | 0.037 sig |
| SECONDARY Ambulation |
9.76; 32.89 | < 0.001 sig |
| SECONDARY Oral Intake |
2.19; 3.58 | < 0.001 sig |
| SECONDARY Postoperative Nausea and Vomiting |
1.82; 1.48 | 0.108 |
| SECONDARY Readmission Rates |
3; 4 | 0.159 |
| SECONDARY Foley Catheter Removal |
11.29; 21.17 | < 0.001 sig |
| SECONDARY Postoperative Temperature |
97.54; 97.37 | 0.020 sig |
| SECONDARY Hospital Length of Stay |
81.37; 90.76 | 0.085 |
Summary
Enhanced Recovery After Surgery (ERAS) protocols have been proven to be very successful in specific patient populations. An example is with ERAS for colorectal surgery. ERAS protocols in this patient population have been shown to reduce overall morbidity and hospital length of stay (LOS). At the University of Alabama at Birmingham (UAB), the institution has had successful implementation of ERAS protocols for several surgical specialties including colorectal, breast, spine, gynecology, and gynecology-oncology. However, the institution currently does not have a protocol in place for the most commonly performed surgical procedure - cesarean delivery. At UAB, the institution performs approximately 1,000 cesarean deliveries per year.
The investigators believe that an ERAS protocol will be beneficial for these patients. Currently, there is very little data published on ERAS protocols. Although this patient population is ideal for an ERAS protocol, there are several barriers that have to be overcome. The data published show promising results for ERAS protocols with cesarean delivery. A larger tertiary care center showed earlier discharge with lower re-admission rates with an ERAS pathway.
Currently, the investigators have created a multidisciplinary group at UAB to establish an ERAS protocol for patients undergoing cesarean delivery. This group includes anesthesiologists, obstetricians, nursing, neonatology, pharmacy, and informatics. Once the investigators have implemented this protocol, the investigators would like to perform a retrospective analysis to determine if there are any significant changes in our desired outcomes the investigators will study. Our goal is to demonstrate significantly improved outcomes in the investigators' measured endpoints. The investigators believe that this information will be very useful because although there is a national interest in creating ERAS protocols for cesarean deliveries, there currently is very little published on the subject. The investigators would like to publish the investigators' results and protocol as a resource for other institutions to adopt.
Eligibility Criteria
Inclusion Criteria
Any patient 18 years or older whom is scheduled for an elective cesarean section from one of the participating clinics: Prime Care, Maternal Fetal Medicine (MFM), Obstetrics Complications Clinic (OBCC).
Exclusion Criteria
- Age less than 18 years old;
- urgent or emergent cesarean delivery;
- diagnosis of preeclampsia;
- coagulopathy that contraindicates neuraxial block placement;
- abnormal placentation;
- opioid abuse disorder;
- type C diabetic or greater.
Data sourced from ClinicalTrials.gov (NCT03552822). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.