A Randomised Controlled Trial to Assess the Efficacy of Enhanced Recovery After Surgery (ERAS) protocol in Elective Lumbar Spinal fusion
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Length of hospital stay
研究概览
简要总结
This prospective randomized controlled trial aims to compare Enhanced Recovery After Surgery (ERAS) with traditional perioperative care in elective lumbar spinal fusion patients. The primary outcome is the length of hospital stay (LOS), while secondary outcomes include pain control, analgesic use, mobilization, catheterization, and inflammatory markers. Patients will be stratified and randomized into two groups, with follow-ups at 72 hours, 4-6 weeks, and 3 months postoperatively. The study will enroll 70 patients (35 per group) and analyze data using SPSS v22, with significance set at p<0.05. Ethical clearance has been obtained, and patient confidentiality will be maintained.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Age greater than 18 years 2) Undergoing elective lumbar spinal fusion.
排除标准
- •Patients not consenting for the study.
- •Patients undergoing urgent or emergent surgery.
- •Vulnerable patients such as pregnant women.
- •Infective spine pathology, tumours.
结局指标
主要结局
Length of hospital stay
时间窗: 2 years
次要结局
- Assessment of pain control in the hospital using Visual Analogue Scale (VAS) pain scores before surgery, at discharge, and average daily scores.(2 years)
- Total postoperative analgesic consumption during hospitalization and patient-reported analgesic usage one month post-surgery.(2 years)
- Postoperative mobilization and ambulation in the hospital, including time to ambulation and incidence of hospital falls. Mobilization refers to extremity movement and ambulation denotes walking with or without assistance.(2 years)
- Utilization and duration of Foley catheterization, as well as the need for postoperative straight catheterization.(2 years)
- Assessment of inflammatory markers.(2 years)
研究者
MUMMAKA SIVA PRASAD
SVIMS , TIRUPATI, INDIA