Cesarean Section Via Enhanced Recovery

NCT03552822 | Completed Results DMC

• 1 other identifier: 45678910
• Study Type: observational
• Target: 541
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cesarean Section

Outcome Measures

Primary Outcomes (1)

• Opioid Consumption

  Measurement of opioid consumption in oral morphine equivalents

  From 1 to 72 hours post surgery

Secondary Outcomes (8)

• Overall Average Pain Scores

  From 1 to 72 hours post surgery

• Ambulation

  From 1 to 72 hours post surgery

• Oral Intake

  From 1 to 24 hours post surgery

• Postoperative Nausea and Vomiting

  From 1 to 72 hours post surgery

• Readmission Rates

  Up to 21 days post surgery

Study Arms (2)

ERAS Implemented Group

Enhanced recovery after surgery (ERAS) protocol implementation for patients undergoing cesarean delivery.

Other: ERAS Protocol Implementation

Pre-ERAS - Non-ERAS Implemented Group

Non-Enhanced recovery after surgery (ERAS) protocol implementation for patients undergoing cesarean delivery.

Interventions

ERAS Protocol Implementation OTHER

Implementation of ERAS Protocol Implementation

ERAS Implemented Group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Based on gender identity
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients 18 years or older whom is scheduled for an elective cesarean section from one of the participating clinics: Prime Care, MFM, OBCC.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35249, United States

Location

Results Point of Contact

• Title: Dr. Mark Powell
• Organization: University of Alabama at Birmingham

mfpowell@uabmc.edu

2059346007

Study Officials

• Sara A Lester, MD

  UAB Department of Anesthesiology, Critical Care Division

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 29, 2018
• First Posted: June 12, 2018
• Study Start: July 1, 2018
• Primary Completion: December 31, 2018
• Study Completion: February 1, 2020
• Last Updated: August 8, 2022
• Results First Posted: March 7, 2022

Record last verified: 2022-08

Locations

US (1)