Erectus Nerve Block for Lumbar Spine Surgery : a Prospective Randomized Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- morphine consumption (mg)
研究概览
简要总结
: Spine surgery induced severe postoperative pain. Several techniques as intravenous multimodal analgesia have been proposed to reduce pain relief and morphine rescue over the first postoperative days. Regional anesthesia using the erectus nerve block is a simple infiltration across lamina of the vertebra: Ultrasound-guided posterior ramus of spinal nerve block for anesthesia and analgesia in lumbar spinal surgery This study compared erector nerve block with local anesthetic vs placebo to reduce pain and morphine rescue after lumbar spine surgery. The investigators hypothesized that eructor nerve block induced a large block from L1 to L5 that induced posterior nerve roots block anesthesia. This block reduced pain after surgery.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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> 18years and <80 years
- •lumbar spine surgery (2-4 levels)
- •posterior approach
排除标准
- •age < 18yrs
- •<50 kg and >120 kg
- •renal or hepatic severe desease
- •no French speaking
- •emergency surgery
- •local or systemic infection
- •surgical resumption of the surgical site
- •surgery involving a thoracic approach
- •allergy to local anesthetics
研究组 & 干预措施
Treated
active treatment (Local anaesthetic): Local administration of ropivacaine 30 mL (5mg/mL)
干预措施: Local administration of ropivacaine (Drug)
Control
Local administration of Placebo ( Saline Solution)
干预措施: Local administration of placebo (saline solution) (Drug)
结局指标
主要结局
morphine consumption (mg)
时间窗: 24 Hours after surgery
Quantity administered in the post-interventional monitoring room and in hospitalization via a self-controlled morphine pump by the patient
次要结局
- chronic pain: DN4 questionnaire(Questionnaire DN4 at 3 months)
- Length of hospital stay(hospital length of stay, an average of 4 days)
- Length of stay in the post-intervention care unit(Day 1)
- pain at rest and at movement: Visual Analogic scale(Day 1 to Day 3, Day od hospital discharge and month 3)
- Patient Satisfaction: visual analogic scale(Day of hospital discharge, an average of day 4)
- Adverse events(from surgery to 3 months)
- Patient Quality of life: EQ-5D Questionnaire(3 months)