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临床试验/NCT04752410
NCT04752410已完成不适用

Selective Trunk Block: A Prospective Non-Randomized Study to Evaluate Block Dynamics, Effects on Ipsilateral Hemidiaphragmatic (Phrenic Nerve) Function and Efficacy for Upper Extremity Surgery

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年2月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Changes of motor block of the upper extremity

研究概览

简要总结

Brachial plexus block (BPB) is frequently used as the sole anesthetic technique for upper extremity surgery. The choice of technique often depends on the site of surgery because the extent of sensory-motor blockade after a BPB varies with the technique used. The investigator is not aware of any single BPB technique described to date that can consistently produce surgical anesthesia of the whole ipsilateral upper extremity. However, occasionally surgery entails that the whole upper extremity, i.e. from the shoulder to the elbow, or even the forearm, wrist or hands. This clinical challenge has been addressed previously using a combination of BPB techniques. The investigator has recently demonstrated that it is feasible to accurately identify majority of the main components of the brachial plexus above the clavicle, including the three trunks, using ultrasound imaging. Since majority of the innervation of the upper extremity, i.e. shoulder, arm, elbow, forearm, wrist and hand, originates from the three trunks of the brachial plexus, the investigator hypothesized that selectively blocking upper, middle, and inferior trunks of the brachial plexus will produce surgical anesthesia of the whole ipsilateral upper extremity. This study is a continuation of a previously approved study with title "Selective Trunk Brachial Plexus Block: A Prospective Non-Randomized Study of Intervention" [NCT04510259] after the amendment (study title, protocol and increased sample size) was rejected by local IRB and suggested to submit as a new protocol. The aim of this study is to assess a novel brachial plexus block technique, the selective trunk block (SeTB), and provide preliminary clinical evidence of its effectiveness in producing surgical anesthesia of the whole ipsilateral upper extremity.

详细描述

Brachial plexus block (BPB) is frequently used as the sole anesthetic technique for upper extremity surgery. The choice of technique often depends on the site of surgery because the extent of sensory-motor blockade after a BPB varies with the technique used. The investigator is not aware of any single BPB technique described to date that can consistently produce surgical anesthesia of the whole ipsilateral upper extremity (shoulder to fingers). However, occasionally surgery entails that the whole upper extremity is anesthetized, i.e. from the shoulder to the elbow, or even the forearm, wrist or hands. This clinical challenge has been addressed previously using a combination of BPB (hybrid) techniques. The investigator has recently demonstrated that it is feasible to accurately identify majority of the individual components of the brachial plexus above the clavicle, including the three trunks, using ultrasound imaging. Since majority of the innervation of the upper extremity, i.e. shoulder, arm, elbow, forearm, wrist and hand, originates from or pass through the three trunks of the brachial plexus, the investigator hypothesized that selectively blocking the upper, middle, and inferior trunks of the brachial plexus will produce surgical anesthesia of the whole ipsilateral upper extremity, except for the area innervated by the intercostobrachial nerve (T2 - medial aspect of the upper arm). The investigator refers this novel technique as "selective trunk block" (SeTB). Currently there are no published data on block dynamics, safety or efficacy of SeTB. In addition, there may be a potential advantage that phrenic nerve can be spared, so this blockade will not affect the respiratory function as it is common to see phrenic nerve palsy after interscalene BPB (100%) and supraclavicular BPB (50-67%). This study is a continuation of a previously approved study with title "Selective Trunk Brachial Plexus Block: A Prospective Non-Randomized Study of Intervention" [NCT04510259] after the amendment (study title, protocol and increased sample size) was rejected by local IRB and suggested to submit as a new protocol. The aim of this study is to assess a novel brachial plexus block technique, the selective trunk block (SeTB), and provide preliminary clinical evidence of its effectiveness in producing surgical anesthesia of the whole ipsilateral upper extremity.

研究设计

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

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •elective upper extremity surgery
  • •emergency upper extremity surgery

排除标准

  • •Patient refusal
  • •pregnancy
  • •local skin site infection
  • •allergy to local anesthetics
  • •bleeding tendency
  • •pre-existing neurological deficit
  • •pre-existing neuromuscular disease.

研究组 & 干预措施

Selective Brachial plexus block

Experimental

Selective brachial plexus block will be done under ultrasound guidance to patients scheduled for upper extremity surgeries. Local anesthetic agents (a mixture of 2% lidocaine with 1:200,000 epinephrine and 0.5% levobupivacaine in a total of 25ml) will be injected at the superior, middle, and inferior trunks of the brachial plexus in order to anesthetize the whole upper limb.

干预措施: Selective Brachial Plexus Block (Procedure)

结局指标

主要结局

Changes of motor block of the upper extremity

时间窗: within 45 minutes after the block at 5 minutes interval

Motor blockade will be graded using a 3-points scale revising from previous study: 2=no block, 1=paresis and 0=paralysis. Motor blockade of each individual nerve in the anesthetized upper extremity will be evaluated by testing for opposition of thumb with the index finger (median nerve), wrist extension (radial nerve), thumb opposition with little finger (ulnar nerve), elbow flexion (musculocutaneous nerve) abduction of shoulder (axillary nerve), and external rotation of the arm with elbow flexed and simulate emptying a can motion and test for power against resistance (Suprascapular nerve). The onset of motor block for each nerve will be defined as motor grading at each nerve =\<1. Complete block will be defined as a sensory and motor block score of '0' in all nerves functions.

Changes of sensory block of the upper extremity

时间窗: within 45 minutes after the block at 5 minutes interval

Sensation to coldness (ice) will be tested at the median (lateral three and half digits on the palmar side), radial (dorsal side of hand), ulnar (medial one and a half digits), musculocutaneous (lateral side of the forearm) and axillary (skin over the lower deltoid) and graded using a verbal rating scale (VRS:0-100, 100=normal sensation, 0=no sensation). Onset of sensory block for each nerve will be defined as the time that it took to achieve a sensory block score of =\<30.

Readiness for surgery

时间窗: within 45 minutes after the block at 5 minutes interval

overall sensory scores =\<30 (VRS: 0-100, 100=normal sensation, 0=no sensation) and motor score =\<1 (3-points scale, 2=no block, 1=paresis, 0=paralysis) in all the nerves tested.

次要结局

  • Changes of the Diaphragmatic function(Baseline (before brachial plexus block) and at 30 minutes after block)

研究者

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

Prof Manoj K Karmakar

Professor

Chinese University of Hong Kong

研究点 (1)

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