Enhanced Recovery After Spine Surgery: A Prospective Randomized Controlled Trial to Assess Quality of Recovery and the Biochemical Stress Response to Lumbar Fusion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Patient Score on QoR40 Inventory.
研究概览
简要总结
Enhanced recovery pathways (ERP) after surgery have been shown to decrease length of stay and perioperative complications in a range of surgical specialties. To date, ERPs has not been studied in patients presenting for spine surgery. The investigators have recently developed an interdisciplinary pathway for spine surgery patients based on the latest available evidence and guidelines. The aim of this trial is to compare the investigators enhanced recovery pathway with conventional perioperative management in patients undergoing 1-2 level posterior lumbar fusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Any patient presenting for 1 or 2 level posterior lumbar fusion.
排除标准
- •Cognitive impairment (baseline dementia, cognitive dysfunction or inability to consent to participate).
- •Kidney disease: GFR <60 mL/min/1.73 m2 for 3 months or more, irrespective of cause (Levey et al., 2012).
- •Liver disease: transaminitis, cirrhosis, hepatitis, hypoalbuminemia, coagulopathy.
- •Pre-existing bowel disease (inflammatory bowel disease, colectomy/ colostomy/diverticular disease).
- •Allergy/intolerance/contraindication to any medication or component included in the ERAS pathway protocol.
- •Patients whose primary or preferred language is not English.
结局指标
主要结局
Patient Score on QoR40 Inventory.
时间窗: Postoperative Day 3
The Quality of Recovery 40 (QoR40) is a 40-item questionnaire which assesses five dimensions of recovery after surgery and anesthesia: comfort, emotions, physical independence, patient support and pain. The QoR40 has been validated for both clinical and research use. The QoR-40 has a possible score of 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery).
次要结局
- Time to Post-operative Oral Intake.(Postoperative Day 1)
- Length of Stay and Time From Surgery to Meeting Discharge and Physical Therapy Goals.(Postoperative Day 5)
- Pain Control: Opioid Consumption.(48 hours after surgery)
- Levels of Plasma Markers of Surgical Stress: IL-6 (pg/ml).(Postoperative Days 0, 1, and 3)
- Pain Control: NRS Rating Scales of Pain After Physical Therapy on Postoperative Day 1(Postoperative Day 1)
- Levels of Plasma Markers of Surgical Stress: Cortisol (mcg/dl).(Postoperative Days 0, 1, and 3)
- Levels of Plasma Markers of Surgical Stress: CRP (mg/dL).(Postoperative Days 0, 1, and 3)
- Number of Participants With Post-operative Nausea, Vomiting and Ileus(Postoperative Day 5)
- Levels of Plasma Markers of Surgical Stress: Insulin Resistance (µIU/ml).(Postoperative Days 0, 1, and 3)
- Number of Participants With Presence of Delirium/Confusion, Infection, DVT/PE(Entire Hospital Admission, but Measure at Discharge (Up to Postoperative Day 5))