Adductor Canal Block and Effect of 10 Versus 30 ml Ropivacaine on Muscle Strength: a Randomized Study in Healthy Volunteers
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Number of subjects with reduced quadriceps strength
研究概览
简要总结
To investigate whether reducing the volume (30 versus 10 ml) ropivacaine injected can reduce the number of subjects with impaired muscle strength following adductor canal block. We hypothesized that adductor canal block with 10 ml 0.1% ropivacaine preserves quadriceps strength compared with an adductor canal block with 30 ml.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 30 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •18-30 years
- •Body Mass Index 18-25
排除标准
- •Allergy to study medication
- •Earlier trauma or surgery to the lower limb
- •Diabetes Mellitus
研究组 & 干预措施
30 ml
30 ml ropivacaine 0.1%, single bolus
干预措施: Adductor canal block with ropivacaine 0.1% (Procedure)
10 ml
10 ml 0.1% ropivacaine, single bolus
干预措施: Adductor canal block with ropivacaine 0.1% (Procedure)
结局指标
主要结局
Number of subjects with reduced quadriceps strength
时间窗: 0.5 to 6 hours post block
The difference between the two volumes in number of subjects experiencing a reduction in quadriceps muscle strength by more than 25% from baseline in two consecutive assessments.
次要结局
- Quadriceps strength calculated as AUC(30 minutes to 6 hours post block)
- Quadriceps strength in percentage of baseline(2, 3 and 4 hours post block)
- Modified 30-second Chair Stand test(2 and 4 hours post block)
- VAS pain scores during warmth stimulation(Mean value for the periode 30 minutes - 6 hours post block)
研究者
Pia Jaeger
Principal Investigator
Rigshospitalet, Denmark