Evaluation of Enhanced Recovery After Surgery (ERAS) Protocol on Postoperative Recovery in Elective Cesarean Sections
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Time to First Mobilization After Cesarean Section
研究概览
简要总结
This study evaluates the effect of the Enhanced Recovery After Surgery (ERAS) protocol on early postoperative recovery in women undergoing elective cesarean section.
Eighty-four pregnant women, aged 18 years or older, at 37 weeks of gestation or beyond, without chronic medical conditions, and classified as ASA I-II, were enrolled. Participants were randomly assigned to either:
ERAS group - received the ERAS protocol, including early oral intake, early mobilization, multimodal analgesia, and enhanced perioperative care
Control group - received standard perioperative cesarean section care
The study compared breastfeeding initiation time, gas passage, oral intake, mobilization time, and postoperative pain scores (VAS) between the two groups.
The aim is to determine whether ERAS can accelerate recovery, reduce pain, and improve maternal comfort after elective cesarean delivery.
详细描述
Enhanced Recovery After Surgery (ERAS) protocols aim to accelerate postoperative recovery, reduce complications, and shorten hospital stays. While ERAS has been widely implemented in general and gynecologic surgeries, its application in obstetric surgery, particularly elective cesarean delivery, remains limited.
This single-center, prospective, randomized clinical trial was conducted at the University of Health Sciences, Istanbul Gaziosmanpasa Training and Research Hospital, between October 2022 and December 2022. Eighty-four women scheduled for elective cesarean section were enrolled. Eligible participants were 18 years or older, at ≥37 weeks of gestation, ASA I-II, without chronic comorbidities, and provided written informed consent.
Participants were randomized (1:1) into two groups:
ERAS group: Managed with ERAS protocol including early oral intake, early mobilization, multimodal analgesia with opioid-sparing strategies, prophylactic antiemetics, early urinary catheter removal, and gum chewing to stimulate bowel function.
Control group: Managed with standard perioperative cesarean care including delayed oral intake, standard pain management, and later mobilization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Pregnant women aged 18 years or older
- •Gestational age ≥37 weeks
- •Classified as ASA I or ASA II
- •Scheduled for elective cesarean section under spinal anesthesia
- •Able and willing to provide informed consent
- •No chronic systemic diseases
排除标准
- •Age <18 years
- •Gestational age <37 weeks
- •Emergency cesarean delivery
- •ASA III or higher
- •Presence of obstetric complications (e.g., preeclampsia, placenta previa, placental abruption, fetal distress)
- •Chronic comorbidities (e.g., diabetes, hypertension, cardiac or pulmonary disease)
- •Declines spinal anesthesia or unable to provide consent
研究组 & 干预措施
ERAS Protocol Group
Participants in this arm will receive the Enhanced Recovery After Surgery (ERAS) protocol during elective cesarean section. The ERAS protocol includes early oral intake, early mobilization, opioid-sparing multimodal analgesia, prophylactic antiemetics, early urinary catheter removal, and gum chewing to stimulate bowel function. Postoperative outcomes such as breastfeeding initiation, gas passage, oral intake time, mobilization, and VAS pain scores will be evaluated.
干预措施: Enhanced Recovery After Surgery (ERAS) Protocol, which includes early oral intake, early mobilization, opioid-sparing multimodal analgesia, prophylactic antiemetics, early urinary catheter removal, an (Behavioral)
Standard Care Group
Participants in this arm will receive standard perioperative cesarean care, which includes overnight fasting, delayed oral intake until gas passage, routine analgesia with paracetamol, NSAIDs and opioids as needed, later urinary catheter removal, and routine postoperative mobilization. Outcomes will be assessed similarly to the ERAS group.
干预措施: Enhanced Recovery After Surgery (ERAS) Protocol, which includes early oral intake, early mobilization, opioid-sparing multimodal analgesia, prophylactic antiemetics, early urinary catheter removal, an (Behavioral)
结局指标
主要结局
Time to First Mobilization After Cesarean Section
时间窗: Within 24 hours postoperatively
Time from the end of elective cesarean section surgery to the patient's first ambulation, measured in hours. Early mobilization reflects enhanced postoperative recovery and is a key indicator of the ERAS protocol's effectiveness.
次要结局
- Incidence of Postoperative Nausea and Vomiting(Within 48 hours postoperatively)
研究者
Havva Betül Bacak
M.D
Gaziosmanpasa Research and Education Hospital