Clinical Outcomes in Patients Undergoing Cesarean Section Via the Enhanced Recovery After Surgery (ERAS) Pathway: a Retrospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 541
- 试验地点
- 1
- 主要终点
- Opioid Consumption
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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).
排除标准
- •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.
结局指标
主要结局
Opioid Consumption
时间窗: From 1 to 72 hours post surgery
Measurement of opioid consumption in oral morphine equivalents
次要结局
- Postoperative Nausea and Vomiting(From 1 to 72 hours post surgery)
- Ambulation(From 1 to 72 hours post surgery)
- Readmission Rates(Up to 21 days post surgery)
- Foley Catheter Removal(From 1 to 24 hours post surgery)
- Overall Average Pain Scores(From 1 to 72 hours post surgery)
- Oral Intake(From 1 to 24 hours post surgery)
- Postoperative Temperature(1 hour post surgery)
- Hospital Length of Stay(Time of admission until time of discharge, generally not over one week)
研究者
Mark Powell
Principal Investigator
University of Alabama at Birmingham