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临床试验/NCT01058525
NCT01058525已完成4 期

Influence of Ultrasonographic Hydro-dissection With Glucose 5% Solution on Median Nerve Block Efficiency: a Prospective and Randomized Study

Hopital Foch2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2010年1月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
发起方
Hopital Foch
入组人数
100
试验地点
2
主要终点
Onset time of sensory blockade (light touch test: total loss of sensation at the two distal phalanges of index)

研究概览

简要总结

The real-time visualization of a needle and nerve during an ultrasound-guided nerve block can be challenging. These difficulties may partly explain the systemic complications of local anesthetics under ultrasound. Injection of small amounts of a solution around the anesthetized nerve (hydro-dissection) has been proposed to enhance contrast outlining its borders and also to improve the visualization of the needle tip. The glucose solution 5% solution is interesting because it allows, unlike saline, to maintain the motor response with neurostimulation. The hydro-dissection can be particularly useful when one suspect hypoechoic vessels near the nerve to be anesthetized. Thereby, the nerve well demarcated and separated from the vessels, injection of local anesthetic is performed in the circumferential diffusion space (like a small pocket) without redirecting needle.

The influence of this hydro-dissection on the nerve block efficiency is unknown. The nerve block quality can be improved because the entire anesthetic is injected in contact with the nerve, but it can also be reduced due to the dilution of the local anesthetic by the glucose solution.

In this randomized study, the investigators test the hypothesis that hydro-dissection does not alter the nerve block onset time.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients with an ASA physical status I-II scheduled for elective ambulatory surgery of the hand or wrist involving the median nerve

排除标准

  • Patients with type 1 or 2 diabetes mellitus,
  • History of clinical or laboratory evidence of abnormal bleeding,
  • Infection at the injection site,
  • Allergy to local anesthetic,
  • Preexisting central or peripheral muscular or neurological disease (for example: carpal tunnel syndrome)

结局指标

主要结局

Onset time of sensory blockade (light touch test: total loss of sensation at the two distal phalanges of index)

时间窗: 30 minutes after injection

次要结局

  • Nerve block complication(one month)
  • Duration of the puncture procedure(30 minutes after the beginning of the procedure)
  • Onset time for motor blockade(30 minutes after injection)
  • Success rate (% of patients with total light touch block at index finger within 30 min evaluation period)(30 minutes after injection)
  • Successful surgical anesthesia(30 minutes after injection)
  • Duration of nerve blockade(12 hours)
  • Onset time of sensory blockade (cold test at index finger and thenar eminence)(30 minutes after injection)
  • Onset time (light touch test at thenar eminence)(30 minutes after injection)

研究者

发起方
Hopital Foch
申办方类型
Other
责任方
Sponsor

研究点 (2)

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