NCT01956617已完成不适用
The Mininimum Effective Anaesthetic Volume of Local Anaesthetic in Ultrasound-guided "Shamrock" Lumbar Plexus Block
Oslo University Hospital4 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2013年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- minimum effective volume
研究概览
简要总结
The "Shamrock method" is a new ultrasound-guided lumbar plexus block. The aim of the study is to determine the minimum effective volume of ropivacaine 0.5% required to produce an effective lumbar plexus block with this method. Using the Dixon and Massey up-and-down method study design, 30 patients scheduled for elective total hip and knee arthroplasty will be included in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •orthopaedic patients scheduled for elective hip and knee arthoroplasty
- •ASA 1 - 2 or stable ASA 3
- •age between 18 and 70 years
- •good ability to communicate and to cooperate
排除标准
- •ASA > 3 or unstable ASA 3
- •BMI > 32
- •chronicle pain
- •nephrological diseases or nephropathy
- •known contraindications against the use of local anaesthetics
- •pregnancy
结局指标
主要结局
minimum effective volume
时间窗: from day 1 up to 20 weeks
The primary outcome measure (MEV) is based on 30 measurements in 30 patients (secondary outcome measure: block success). MEV is determined by Dixon and Massey up-and-down method when all patients have been tested in the study
次要结局
- block success(Day 1)
研究者
Axel Rudolf Sauter
MD. PhD
Oslo University Hospital
研究点 (4)
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