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临床试验/NCT02086643
NCT02086643已完成4 期

The Retroclavicular Approach for Regional Anesthesia of the Upper Limb in Patients With BMI ≥ 30 kg/m2 : A Descriptive Study

Université de Sherbrooke2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2013年12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
32
试验地点
2
主要终点
Surgery completion under regional block

研究概览

简要总结

The goal of this study is to determine the success rate of the retroclavicular approach for the anesthesia of the upper limb in the obese patient population (BMI ≥ 30 kg/m2)

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.

It is recognized that regional anesthesia is more difficult to perform in obese patients. Anatomic landmarks are harder to localize in this population and ultrasound guidance is more difficult because of the attenuation of the ultrasound beam by adipose tissue. The complication rate of regional techniques is also reported to be higher in the obese patient population.

Since the retroclavicular variant of the infraclavicular approach for the anesthesia of the brachial plexus offers a better needle visualisation, we believe that this technique can be used successfully in the obese patient population with a low complication rate.

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

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
  • BMI ≥ 30 kg/m2

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

结局指标

主要结局

Surgery completion under regional block

时间窗: Success is defined at end of surgery for which block was done, generally within 1 to 3 hours after block is performed

Success rate is defined as the completion of the intended surgery under regional anesthesia with retroclavicular block without the need for a rescue technique. These techniques are defined as: adding local anesthetic locally by surgeon, rescue intravenous narcotics in excess of 1 microgram per kilogram of patient weight, need for general anesthesia, rescue distal neural blockage by anesthesiologist. Patient sedation with midazolam 1 to 2 mg IV or propofol perfusion up to 50 mcg/kg/min is allowed for patient comfort during the surgery and is not considered a rescue technique.

次要结局

  • Motor Block Progression(Assessed 10, 20, 30 minutes after the block)
  • Use of narcotic for tourniquet pain(Assessed while surgery in under process)
  • Sensitive block progression(Assessed 10, 20 and 30 minutes after block completion)
  • Duration of the Block's Effects(Assessed 48 hours after the block)
  • Early Complication Rate(Assessed during block performance, throughout surgery and in the PACU. Generally during a period of 4-6 hours after block completion)
  • Needle visualization(Assessed after study completion, once all 30 patients will have been completed. Assessment will take place in the first 4 weeks after all 30 patients have been recruited)
  • Rate of Neurostimulation Usage(Assessed during the block)
  • Failure because of poor ultrasound visualization(Assessed during the performance of the nerve block)
  • Technique duration(Time required in seconds for the retroclavicular block technique completion, generally under 15 minutes)
  • Late Complication Rate(Assessed 48 hours after the block)
  • Patient discomfort(Assessed 1 minute after block completion)
  • Patient satisfaction(Assessed 48 hours after 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 (2)

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