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临床试验/NCT01852396
NCT01852396已完成4 期

Ultrasound-Guided Brachial Plexus Regional Anesthesia by the Novel Retroclavicular Approach : A Feasibility Study

Université de Sherbrooke1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2013年4月1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
入组人数
50
试验地点
1
主要终点
Success Rate of the Block

研究概览

简要总结

The goal of this study is to demonstrate that the novel retroclavicular approach is a safe, fast and effective technique for ultrasound-guided brachial plexus anesthesia.

详细描述

Classic infraclavicular approach of the brachial plexus involves a needle puncture below the clavicle and advancing the needle with a 45-60 degree angle from cephalad to caudad. The aim is to advanced the block needle posterior to the axillary artery and to deposit the local anesthetic at that point, near the posterior cord. A "U" shaped spread around the artery should ensure distribution around all three cords. Ultrasound guidance is highly recommended and neurostimulation is optional.

The retroclavicular approach is a variant to this classical technique. Ultrasound probe is positioned initially below the clavicle in a manner similar to the classic approach but is then rotated in a clockwise fashion (right arm) or counter-clockwise fashion (left arm) for about 25-35 degrees. The puncture site is just behind the clavicle at the most lateral point available. If initial entry point is optimal, needle direction is then parallel to ultrasound probe. The final aim and position of block needle is identical to classical approach. Entry point ensures a parallel alignment of the needle and the ultrasound beam, thus enabling almost perfect visualization of both artery, cords and block needle. This is turn optimizes safety, rapidity of technique, efficiency and efficacy.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

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

入选标准

  • •Elective or Urgent Surgery of the hand, wrist or forearm
  • •18 years and older
  • •Ability to consent
  • •American Society of Anesthesiologists class 1 to 3

排除标准

  • •Infection at the site of infection
  • •Abnormal anatomy at the site of infection
  • •Coagulopathy
  • •Severe Pulmonary Disease
  • •Preexisting neurological symptom(s) in the operated arm
  • •Pregnant patients
  • •Patients weighing less than 50 kg
  • •Allergy to amide type local anesthetics

研究组 & 干预措施

Regional anesthesia

Experimental

Recruit 50 patient having elbow, forearm, wrist or hand surgery and block brachial plexus using the novel retroclavicular approach

干预措施: Retroclavicular block (Procedure)

结局指标

主要结局

Success Rate of the Block

时间窗: Assessed 30 minutes after block completion

Success is defined as complete sensory loss in the distribution of the radial, median, ulnar, musculocutaneous, and medial cutaneous nerves of the forearm and hand.

次要结局

  • Surgical success rate(Defined at the beginning of surgery until the end of surgery)
  • Technique duration(Time required in seconds for the retroclavicular block technique completion, assessed during block performance)
  • Needle visualization(Assessed after study completion, once all 50 patients will have been completed. Assessment will take place in the weeks following study completion)
  • Patient discomfort(Assessed immediately after the block)
  • Patient satisfaction(Assessed 48 hours after the block)
  • Sensitive Block Progression(Assessed 10, 20, 30 minutes after the block)
  • Motor Block Progression(Assessed 10, 20, 30 minutes after the block)
  • Complication Rate(Assessed 48 hours after the block)
  • Duration of the Block's Effects(Assessed 48 hours after the block)
  • Use of narcotic for tourniquet pain(Assessed throughout the surgery)
  • Rate of Neurostimulation Usage(Assessed during the block)

研究者

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

Pablo Echave

Anesthesiologist

Université de Sherbrooke

研究点 (1)

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