ERAS Protocol for Single-level Posterior Lumbar Arthrodesis; a Randomized Prospective Study
试验速览
- 阶段
- 4 期
- 发起方
- AZ Nikolaas
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Length of hospital stay
研究概览
简要总结
Enhanced Recovery After Surgery (ERAS) is a multidisciplinary, multimodal approach aiming to improve surgical outcomes. This study compares the length of hospital stay of patients undergoing single-level posterior lumbar arthrodesis and treated with the ERAS protocol with the hospital stay of patients treated according to the standard protocol.
详细描述
Hundred and ten patients scheduled for single-level posterior lumbar arthrodesis (PLIA) will be randomized to be treated by the standard protocol or the Enhanced Recovery After Surgery (ERAS) protocol. The ERAS protocol differs from the standard protocol in 4 phases: pre-operative counseling and intake, day of surgery, the pre-operative patient preparation, the per-operatively used analgesic and anesthetic drug combination, and the post-operative care consisting of a more intensive physical therapy in the ERAS group. It is the objective the mobilize patients more rapidly without compromising the comfort in terms of pain.
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
盲法说明
The interventions described in the patient information brochure make masking impossible
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled for a single level PLIA as treatment of mono segmental degenerative instability, as seen on dynamic X-rays, after the failure of 6 months conservative therapy Capable of understanding the provided information Giving informed consent
排除标准
- •Revision surgery Arthrodesis for trauma, neoplasms, infection, or listhesis due to lysis. High dose opioid use (step 3 of the WHO pain ladder) Diabetes Cognitive impairment (baseline dementia, cognitive dysfunction, or inability to consent to participate).
- •Known kidney insufficiency: GFR <30 mL/min/1.73 m2 Allergy/intolerance/contraindication to any medication or component included in the ERAS pathway protocol Patients with a risk factor for reflux
结局指标
主要结局
Length of hospital stay
时间窗: 2-3 days + 11 days
Number of days hospitalization
次要结局
- Pain intensity(day of discharge)
- 11-days readmission rate(discharge + 11 days)
- Analgesic use, including opioids(2-3)
研究者
Erik Van de Kelft, M.D., PhD
Head of neurosurgery department
AZ Nikolaas