Cesarean Section Via Enhanced Recovery
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|ClinicalTrials.gov Identifier: NCT03552822|
Recruitment Status : Recruiting
First Posted : June 12, 2018
Last Update Posted : January 14, 2020
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.
|Condition or disease||Intervention/treatment|
|Cesarean Section||Other: ERAS Protocol Implementation|
|Study Type :||Observational|
|Estimated Enrollment :||500 participants|
|Official Title:||Clinical Outcomes in Patients Undergoing Cesarean Section Via the Enhanced Recovery After Surgery (ERAS) Pathway: a Retrospective Study|
|Actual Study Start Date :||January 15, 2019|
|Estimated Primary Completion Date :||December 15, 2020|
|Estimated Study Completion Date :||March 1, 2021|
ERAS Implemented Group
Enhanced recovery after surgery (ERAS) protocol implementation for patients undergoing cesarean delivery.
Other: ERAS Protocol Implementation
Implementation of ERAS Protocol Implementation
Pre-ERAS - Non-ERAS Implemented Group
Non-Enhanced recovery after surgery (ERAS) protocol implementation for patients undergoing cesarean delivery.
- Opioid Consumption [ Time Frame: From 1 to 72 hours post surgery ]Measurement of opioid consumption in oral morphine equivalents
- Pain Scores [ Time Frame: From 1 to 72 hours post surgery ]Measurement of pain score post-cesarian section will be obtained using clinical data gathered by the care team providing routine clinical care, and asking routine pain score questions. The scale used is the standard 1-10 pain scale, with 1 being no pain or very mild discomfort, and 10 being very severe pain. Thus, higher values indicate a worse outcome.
- Ambulation Attempts [ Time Frame: From 1 to 72 hours post surgery ]Measurement of number of times patient ambulates post op
- Oral Intake [ Time Frame: From 1 to 24 hours post surgery ]Time to first oral intake
- Postoperative Nausea and Vomiting [ Time Frame: From 1 to 72 hours post surgery ]Treatment for postoperative nausea and vomiting
- Readmission rates [ Time Frame: Up to 21 days post surgery ]Readmissions to the hospital
- Foley catheter removal [ Time Frame: From 1 to 24 hours post surgery ]Time to Foley catheter removal postoperative
- Postoperative temperature [ Time Frame: 1 hour post surgery ]Temperature recorded in post-anesthesia care unit
- Hospital length of stay [ Time Frame: Time of admission until time of discharge, generally not over one week ]Length of stay in hospital post-cesarian
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03552822
|Contact: Adam Sturdivant, MPH||205-934-4042||Adamsturdivant@uabmc.edu|
|Contact: Ayesha Bryant, MDemail@example.com|
|United States, Alabama|
|University of Alabama at Birmingham||Recruiting|
|Birmingham, Alabama, United States, 35249|
|Contact: Adam Sturdivant, MPH 205-934-4042 Adamsturdivant@uabmc.edu|
|Principal Investigator: Mark Powell, MD|
|Study Chair:||Sara A Lester, MD||UAB Department of Anesthesiology, Critical Care Division|