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临床试验/NCT01981746
NCT01981746已完成4 期

Adductor Canal Block and Effect of 10 Versus 30 ml Ropivacaine on Muscle Strength: a Randomized Study in Healthy Volunteers

Rigshospitalet, Denmark2 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2013年11月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
26
试验地点
2
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

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Pia Jaeger

Principal Investigator

Rigshospitalet, Denmark

研究点 (2)

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