A Preemptive Epidural Ropivacaine for Postoperative Pain Relief in Degenerative Lumbar Spine Surgery: A Prospective Randomized Study
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Visual analogue scale 4hour
研究概览
简要总结
This prospective randomized study aims to evaluate the effectiveness of epidural injection of ropivacaine on the relief of pain in patients undergoing laminectomy.
Total 60 patients will be randomized into one of two groups (groupC or groupI) based on Excel number generation.
Patients in group C will receive no medication intraoperatively, and patients in group I will receive epidural injection of 0.1% ropivacaine 10ml before skin incision.
Visual analogue scale pain scores, fentanyl consumption and the frequency at which patients pushed the button (FPB) of a patient-controlled analgesia system will be recorded at 4,12,24,48 hour postoperatively.
详细描述
Patients in group I will receive 0.1% ropivacaine 10 ml before skin incision under guide of C-arm.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •laminectomy
排除标准
- •r/o infection
- •reoperation
- •mental change
- •allergy to local anesthetics
研究组 & 干预措施
epidural injection (group I)
patients in Group I will receive epidural injection of 0.1% ropivacaine 10 ml before skin incision.
干预措施: Ropivacaine (epidural injection) (Drug)
epidural injection group (group C)
control group will receive no medication preoperatively and during operation
干预措施: Placebo (one of medication) (Drug)
结局指标
主要结局
Visual analogue scale 4hour
时间窗: post op 4hour
Patients will be assessed for pain using a visual analogue pain scale (VAS). It is usually a horizontal line, 100 mm in length, anchored by word descriptors at each end; left side end which represents 0 is 'No pain', right side end with 100 is 'Very severe pain'. The patient marks on the line the point that they feel represents their perception of their current state. The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the patient marks. To check the severity of pain VAS will be measured at post op 4hour.
次要结局
- visual analogue scale 24hour(Post Op 24 hour)
- visual analogue scale 12 hour(Post op 12 hour)
- Visual analogue scale 48hour(Post Op 48hour)
- Opioid consumption 4hour(Post Op 4hour)
- Opioid consumption 24hour(Post op 24 hour)
- Opioid consumption 12 hour(Post Op 12 hour)
- Opioid consumption 48hour(Post Op 48 hour)
- FPB 4 hour(Post Op 4 hour)
- FPB 12 hour(post op 12 hour)
- FPB 24 hour(Post Op 24 hour)
- FPB 48 hour(Post Op 48 hour)