Enhanced Recovery After Surgery Versus Standard Recovery for Emergency Caesarean Deliveries at Mbarara Hospital, Uganda: A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Length of hospital stay
研究概览
简要总结
Caesarean section (CS) constitutes a large proportion of the total surgical volume in low-income countries. This rate comes with challenges including surgical complications, shortage of beds, and consequently long waiting time for operations and high costs. These have led to the adoption of ERAS in developed countries in a bid to save costs by reducing hospital length of stay without compromising the health of the mother and her baby.
详细描述
CS is the most common major surgery at Mbarara Hospital (56.2%). This rate comes with challenges including surgical complications, shortage of beds, and consequently long waiting time for operations. Enhanced recovery programs are composed of preoperative, intraoperative and postoperative strategies combined to form a multi-modal pathway. ERAS requires a multidisciplinary team of anesthetists, surgeons and nurses for successful implementation and realization of its advantages. ERAS has been seen to reduce duration of hospital stay, complications and costs. Although many of the elements of enhanced recovery after surgery are similar, it has not been tested in emergency CS and there is limited data about its applicability in low income settings like Uganda where 95% of CS are emergencies. The aim of this study was to assess the impact of ERAS protocols following emergency caesarean delivery in a low resource setting.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Mothers delivering by emergency CS were randomly assigned to either ERAS or routine care arms in a ratio of 1:1. We did simple randomization to either ERAS or routine care arm without any blocks. We generated patient group assignments using the computer algorithm (computer-generated list of random numbers) and placed in identical sealed opaque envelopes. A statistician not involved in the research generated the random number list. The envelopes were opened sequentially by the anesthetist when an eligible patient was encountered. Mothers were recruited into the study by the two research assistants implementing ERAS elements. Single blinding of PI and the two research assistants assessing outcomes was done to minimize bias.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •We included women who were ASA 1 and 2 mothers who were delivering by emergency caesarean section using spinal anesthetic technique.
排除标准
- •Exclusion criteria included refusal to consent, pregnancy complicated by preeclampsia, antepartum hemorrhage, malaria, gestational diabetes mellitus, physical disability that would prevent postoperative mobilization and mental illness precluding comprehension of protocols.
研究组 & 干预措施
Intervention
ERAS arm received;
Preoperative:1. Intravenous (IV) cefazoline 1g 2. IV metoclopromide 10mg, dexamethasone 8mg, ranitidine 150mg
Intraoperative: 1. Hyperbaric bupivacaine 10-15mg plus intrathecal morphine 100mcg 2. Adrenaline 100mcg in 500ml of ringers lactate 3. Individualized goal directed fluid therapy 4. Reinforced counseling and education 5. wound infiltration with isobaric bupivacaine 2mg/kg 6. Rectal diclofenac 100mg and misoprostol 400mcg stat
Postoperative:
- Feeding within 1 hour
- urethral catheter removal at 6-8 hours
- Mobilization at 8-10 hours
- A single fixed dose combination of ibuprofen 400 mg and paracetamol 500 mg 8 hourly
- Tablets Amoxicillin-clavulunate 850mg 12 hourly
干预措施: Enhanced recovery after surgery (ERAS) (Combination Product)
Control
Standard care arm received;
- IV ceftriaxone 2g or ampiclox 2g
- Anesthetists administered IV fluids, vasopressors, and managed hypothermia based on their clinical impressions.
- Oral feeding and breastfeeding were allowed any time after transfer to postnatal ward.
- Urethral catheters were removed between 12-24 hours after surgery.
- Ward nurses and obstetricians made decisions regarding treatment without study staff input or oversight.
干预措施: Enhanced recovery after surgery (ERAS) (Combination Product)
结局指标
主要结局
Length of hospital stay
时间窗: Measured from surgery up to 120 hours.
Length of hospital stay was measured in hours
次要结局
- Complication rates(Pain was assessed after 6 hours postoperative; PONV, pruritus and urine retention were assessed for 24 hours; headache was assessed for 1 week; wound infection, puerperal sepsis and readmission were assessed up to 30 days postoperative)