Prevention of Residual Low Back Pain After Percutaneous Kyphosis(PKP) Using Posterior Branch Block of Spinal Nerve
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 198
- 试验地点
- 1
- 主要终点
- Residual low back pain after operation
研究概览
简要总结
The purpose of this study was to block the posterior branch of lumbar spinal nerve during PKP operation and compare it with the patients without spinal nerve block, so as to verify the effect of posterior branch block of spinal nerve in relieving short-term and long-term residual low back pain after operation.
详细描述
Patients older than 60 years old who underwent Percutaneous kyphosis(PKP) surgery for osteoporotic fractures were randomly divided into two groups. The lumbar spinal nerve branch was blocked with betamethasone and ropivacaine in the experimental group during PKP operation, while the lumbar spinal nerve branch block was not performed in the control group during PKP operation. The low back pain was evaluated at 1 week, 2 weeks, 1 month, 3 months and 6 months after operation using Visual analogue pain score(VAS)scale.So as to compare the effect of lumbar spinal nerve block on residual pain after PKP.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •osteoporotic fracture
- •acute vertebral compression fracture (within 2 weeks)
- •fracture level lower thanT6
排除标准
- •other types of fractures
- •patients younger than 60 years of age,
- •with other disease (metabolic bone disease, metastasis, uncor- rectable coagulopathy, spinal infection, severe cardiopulmonary comorbidity, cognitive disorders etc)
研究组 & 干预措施
posterior branch block of spinal nerve
posterior branch block of spinal nerve during Percutaneous kyphoplasty(PKP)operation
干预措施: posterior branch block of spinal nerve (Procedure)
without posterior branch block of spinal nerve
without posterior branch block of spinal nerve during Percutaneous kyphoplasty(PKP) operation
结局指标
主要结局
Residual low back pain after operation
时间窗: 6 months after operation
Residual low back pain after operation using Visual analogue pain score(VAS) scale, VAS scores range from 0 to 10, more higher score means more severe pain, and residual back pain was defined as a VAS score greater than or equal to 4.
次要结局
未报告次要终点
研究者
WU YAOSEN
Deputy Director of Spinal surgery
Second Affiliated Hospital of Wenzhou Medical University