Comparison of Paravertebral Block Versus Epidural Anesthesia for Surgical Anesthesia of Percutaneous Nephrolithotomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- pain score 12h post operation
研究概览
简要总结
This prospective, randomized study is aimed to assess the efficacy and safety of paravertebral block compared to epidural anesthesia for percutaneous nephrolithotomy. The investigators suppose that paravertebral block is not inferior in controlling the perioperative pain for percutaneous nephrolithotomy compared to epidural block.
详细描述
Background: Percutaneous nephrolithotomy (PCNL) is generally performed under general or neuraxial anesthesia. The investigators have reported three patients who were at high risk of both general anesthesia and neuraxial anesthesia received percutaneous nephrolithotomy with ultrasound guided paravertebral block. Then，The investigators performed ultrasound guided paravertebral block for 45 patients who received percutaneous nephrolithotomy successfully. The investigators' impression is that paravertebral block is as effective as epidural anesthesia for surgical anesthesia of percutaneous nephrolithotomy.
Objectives:To assess the efficacy and safety of paravertebral block compared to epidural anesthesia for surgical anesthesia of percutaneous nephrolithotomy.
Methods: Fifty adult patients undergoing elective percutaneous nephrolithotomy will be randomized to receive ultrasound guided paravertebral block or epidural anesthesia. The primary outcome will be the pain score 12h postoperation. The secondary outcomes will include: time spent to perform block, dose of intraoperative opioids, rate of hypotension need for vasoconstrictors, muscle Power Grading of the lower legs at the end of the operation, anus exhaust time, opioid consumption postoperation, postoperative PONV score and the frequency of vomiting , hospitalization duration and patient satisfaction.
Clinical Implications: Ultrasound guided paravertebral block could be an equally effective and safe alternative to epidural block for surgical anesthesia of percutaneous nephrolithotomy.
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
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists physical statusⅠ-Ⅲ
- •Undergo first stage percutaneous nephrolithotomy
- •Informed consent
排除标准
- •Coagulopathy, on anticoagulants
- •History of surgery on spine
- •Spine deformity
- •A known allergy to the drugs being used
- •Tumor or infection at the site of puncture
- •inability to provide adequate informed consent
- •refusal to participate in the study
研究组 & 干预措施
paravertebral block
patients received ultrasound guided two-segment paravertebral block for percutaneous nephrolithotomy
干预措施: paravertebral block (Procedure)
Epidural
patients received thoracic epidural anesthesia for percutaneous nephrolithotomy
干预措施: epidural anesthesia (Procedure)
结局指标
主要结局
pain score 12h post operation
时间窗: 12 hours postoperation
次要结局
- dose of intraoperative opioids(during operation)
- time spent to perform block(during block)
- rate of hypotension(during operation)
- opioid consumption postoperation(12 hours postoperation)
- postoperative PONV score and the frequency of vomiting(24 hours postoperation)
- Hospitalization duration(10 days postoperation)
- Muscle Power Grading of the lower legs at the end of the operation(12 hours postoperation)
- Patient satisfaction(one day before discharge)
研究者
Wei Mei
Vice Director, Department of Anaesthesiology, Tongji Hospital of Tongji Medical College
Huazhong University of Science and Technology