Value of Target-controlled Intravenous Anaesthesia (TCIVA) to Optimize Coverage of the Low Back Pain Territory in Patients With Chronic Refractory Postoperative Multifocal Low Back and Legpain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Postoperative paresthesia coverage >= 50% of the lower lumbar determined using a paresthesia cover mapping
研究概览
简要总结
Study design 60 patients Monocenter prospective study Randomized in 2 groups 36 months Objectives Demonstrate the superiority of target controlled intravenous anesthesia versus total anesthesia with the low back paresthesia mapping in at least 95% of patients implanted with a multicolumn lead.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years and ≤ 80 years
- •Radicular leg et lumbar pain
- •For more than 3 months after one or many spine surgeries
- •Mixt pain (radicular leg et lumbar) with Neuropathic status
- •Failure of conservative treatment
- •Severe uni or bilateral radicular pain > 5 / 10
排除标准
- •Age <18 years and> 80 years.
- •BMI > 30 kg/m
- •Back pain that can be treated by surgery (discogenic, vertebral instability, ...)
- •Contraindication to TCIVA anesthesia under propofol remifentanil
- •Psychiatric status
- •No signature of informed consent.
- •Women of childbearing without contraception
研究组 & 干预措施
Target-controlled Intravenous Anaesthesia
Patients have a target controlled intravenous anaesthesia to implant the spinal cord stimulation lead with active cooperation during the surgery.
干预措施: Target-controlled intravenous anaesthesia (Procedure)
Total anesthesia
Patients have a total anaesthesia to implant the spinal cord stimulation lead without active cooperation during the surgery.
干预措施: Total anaesthesia (Procedure)
结局指标
主要结局
Postoperative paresthesia coverage >= 50% of the lower lumbar determined using a paresthesia cover mapping
时间窗: 6 months.
次要结局
未报告次要终点