跳至主要内容
临床试验/NCT02990702
NCT02990702Unknown4 期

Retroclavicular Approach vs Infraclavicular Approach for Brachial Plexus Block in Obese

Kahramanmaras Sutcu Imam University0 个研究点目标入组 60 人开始时间: 2017年1月最近更新:
适应症
干预措施

试验速览

阶段
4 期
发起方
入组人数
60
主要终点
Surgery completion under regional block

研究概览

简要总结

The retroclavicular approach for brachial plexus anesthesia requires an optimal angle between the needle and the ultrasound beam. Retroclavicular approach has already been proven effective and safe in the past. The general objective is to provide a formal comparison between the retroclavicular approach and coracoid infraclavicular approach for brachial plexus anaesthesia. This study should represent the differences between the two techniques.

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Double (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

  • 18-80 years
  • Forearm- Hand surgery

排除标准

  • <18 years
  • Local infection
  • Coagulopaty

研究组 & 干预措施

Ultrasound guided retroclavicular block

Active Comparator

Ultrasound guided retroclavicular block group patients (Group R) will receive 30 cc %0.5 Bupivacaine

干预措施: Ultrasound guided retroclavicular block (Other)

Ultrasound guided retroclavicular block

Active Comparator

Ultrasound guided retroclavicular block group patients (Group R) will receive 30 cc %0.5 Bupivacaine

干预措施: Ultrasound guided coracoid infraclavicular block (Other)

Ultrasound guided retroclavicular block

Active Comparator

Ultrasound guided retroclavicular block group patients (Group R) will receive 30 cc %0.5 Bupivacaine

干预措施: Bupivacaine (Drug)

Ultrasound guided retroclavicular block

Active Comparator

Ultrasound guided retroclavicular block group patients (Group R) will receive 30 cc %0.5 Bupivacaine

干预措施: Ultrasound (Device)

Ultrasound guided infraclavicular block

Active Comparator

Ultrasound guided coracoid infraclavicular block group patients (Group C) will receive 30 cc %0.5 Bupivacaine

干预措施: Ultrasound guided retroclavicular block (Other)

Ultrasound guided infraclavicular block

Active Comparator

Ultrasound guided coracoid infraclavicular block group patients (Group C) will receive 30 cc %0.5 Bupivacaine

干预措施: Ultrasound guided coracoid infraclavicular block (Other)

Ultrasound guided infraclavicular block

Active Comparator

Ultrasound guided coracoid infraclavicular block group patients (Group C) will receive 30 cc %0.5 Bupivacaine

干预措施: Bupivacaine (Drug)

Ultrasound guided infraclavicular block

Active Comparator

Ultrasound guided coracoid infraclavicular block group patients (Group C) will receive 30 cc %0.5 Bupivacaine

干预措施: Ultrasound (Device)

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 anaesthesia with retroclavicular block without the need for a rescue technique.

Technique duration

时间窗: Measured directly during the procedure with a chronometer.

The performance time corresponds to the sum of imaging time and needling time. It is expressed in minutes. Analysis of the primary outcome: performance time will be analyzed with a non-inferiority test of the averages, with the objective of finding that the experimental retroclavicular approach is no longer to perform than the coracoid infraclavicular approach.

次要结局

  • Motor Block Progression(Assessed 10, 20, 30 minutes after the block completion)
  • Needle visualization(Assessed one week after study completion)
  • Sensorial block progression(Assessed 10, 20 and 30 minutes after block completion)

研究者

发起方
Kahramanmaras Sutcu Imam University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Bora Bilal

Assistant Proffesor

Kahramanmaras Sutcu Imam University

相似试验