Clinical trial NCT03552822: Cesarean Section Via Enhanced Recovery
Official title: Clinical Outcomes in Patients Undergoing Cesarean Section Via the Enhanced Recovery After Surgery (ERAS) Pathway: a Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cesarean Section
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2018-06-12
Enrollment: 541
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed description: The investigators are implementing an enhanced recovery after surgery (ERAS) protocol for patients undergoing cesarean delivery. The purpose of the ERAS protocol is to optimize care provided to patients (patient education, nutrition, pain management, early ambulation, etc.). The anticipated date of protocol initiation is May 2018. Once this protocol has been in place for approximately 6 months to one year, the investigators would like to retrospectively review data on these patients and compare outcomes to a similarly-matched group of patients the year preceding protocol implementation. Specific outcomes the investigators will assess are: hospital length of stay, post-operative pain scores, opioid consumption, patient satisfaction \[through IRB-approved survey (protocol X300001121)\], surgical site infection rates, readmission rates, and unscheduled clinic and maternal evaluation unit (MEU) visits before the first scheduled postpartum visit. The investigators also plan to track compliance monthly with the adherence to the protocol. Since the investigators want to track compliance (both as a quality improvement project as well as research), the investigators are requesting (Institutional Review Board) IRB approval now.

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:

1. Age less than 18 years old;
2. urgent or emergent cesarean delivery;
3. diagnosis of preeclampsia;
4. coagulopathy that contraindicates neuraxial block placement;
5. abnormal placentation;
6. opioid abuse disorder;
7. type C diabetic or greater.

Primary outcomes:
measure: Opioid Consumption
timeFrame: From 1 to 72 hours post surgery
Secondary outcomes:
measure: Overall Average Pain Scores
timeFrame: From 1 to 72 hours post surgery
measure: Ambulation
timeFrame: From 1 to 72 hours post surgery
measure: Oral Intake
timeFrame: From 1 to 24 hours post surgery
measure: Postoperative Nausea and Vomiting
timeFrame: From 1 to 72 hours post surgery
measure: Readmission Rates
timeFrame: Up to 21 days post surgery
measure: Foley Catheter Removal
timeFrame: From 1 to 24 hours post surgery
measure: Postoperative Temperature
timeFrame: 1 hour post surgery
measure: Hospital Length of Stay
timeFrame: Time of admission until time of discharge, generally not over one week
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: UAB Department of Anesthesiology, Critical Care Division
name: Sara A Lester, MD
role: STUDY_CHAIR
References: