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Completed

NCT Number: NCT03552822

Cesarean Section Via Enhanced Recovery

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.

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Key information

Conditions

Cesarean Section

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35249, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ERAS Protocol Implementation

Other

Implementation of ERAS Protocol Implementation

Primary outcomes

  1. Opioid Consumption

    Time frame: From 1 to 72 hours post surgery

    Measurement of opioid consumption in oral morphine equivalents

Secondary outcomes

  1. Overall Average Pain Scores

    Time frame: From 1 to 72 hours post surgery

    Pain scores 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. For each subject, pain scores obtained during the 72 hours post-surgery will be averaged to obtain an overall average pain score.

  2. Ambulation

    Time frame: From 1 to 72 hours post surgery

    Length of time between surgery and first recorded ambulation. A total of 9 patients are missing data in the electronic medical record and this was accounted for in our analysis but are not represented in the numbers below.

  3. Oral Intake

    Time frame: From 1 to 24 hours post surgery

    Time to first oral intake of clear liquids. A total of 9 patients are missing data in the electronic medical record and this was accounted for in our analysis but are not represented in the numbers below.

  4. Postoperative Nausea and Vomiting

    Time frame: From 1 to 72 hours post surgery

    Treatment for postoperative nausea and vomiting was assessed using the total amount of ondansetron given postoperatively.

  5. Readmission Rates

    Time frame: Up to 21 days post surgery

    Readmissions to the hospital

  6. Foley Catheter Removal

    Time frame: From 1 to 24 hours post surgery

    Time to Foley catheter removal postoperative. A total of 9 patients are missing data in the electronic medical record and this was accounted for in our analysis but are not represented in the numbers below.

  7. Postoperative Temperature

    Time frame: 1 hour post surgery

    Temperature recorded in post-anesthesia care unit. A total of 9 patients are missing data in the electronic medical record and this was accounted for in our analysis but are not represented in the numbers below.

  8. 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. A total of 9 patients are missing data in the electronic medical record and this was accounted for in our analysis but are not represented in the numbers below.

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

Clinical Outcomes in Patients Undergoing Cesarean Section Via the Enhanced Recovery After Surgery (ERAS) Pathway: a Retrospective Study

Important dates

Study start
2018
Primary completion
2018
Study completion
2020
First posted
Jun 12, 2018
Registry last updated
Aug 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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