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临床试验/NCT03512990
NCT03512990Unknown不适用

Clinical And Anatomic Study Of An Ultrasound-Guided Selective Block Of The Superior Trunk Of The Brachial Plexus. Description Of A New Approach

Federal University of São Paulo2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2018年4月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
10
试验地点
2
主要终点
Superior Trunk Successful Block

研究概览

简要总结

Introduction

Interscalene brachial plexus block is the most commonly performed regional anesthesia technique to promote analgesia for shoulder surgeries. However, one of limitations is the risk of phrenic nerve palsy despite injection of low volumes, being contraindicated in patients with limited pulmonary reserve.

Burckett-St.Laurent et al described an alternative approach to avoid phrenic block - the superior trunk approach.

In this case series, the investigators suggest a modification of Burckett-St.Laurent's technique. The objective of this study is to evaluate efficacy, phrenic nerve function and contrast dispersion in cadavers after performing this new approach.

Materials and methods

The study was approved by Institutional Review Board of our institution. To perform the superior trunk approach described by Burckett-St.Laurent, C5 and C6 nerve roots are identified within the interscalene groove and traced distally to where they coalesce into the superior trunk, proximal to the takeoff of the suprascapular nerve. Burckett-St.Laurent et al suggest spreading local anesthetic around superior trunk at this point.

The investigators suggest an injection more distally, where superior trunk is in costoclavicular space below omohyoid muscle, proximal to the suprascapular outlet. The needle is advanced below the prevertebral layer of deep cervical fascia, avoiding that the tip of the needle lies in the fascial plane between investing layer of deep vertebral fascia and prevertebral layer, a loose fascial plane where lymph node chain is located and may allow postero-anterior dispersion toward phrenic. To guarentee right position of the tip the investigators suggest an intracluster pattern of spread.

Patients scheduled for rotator cuff surgery will receive 6 mL of 0,5% bupivacaine in this new approach. Successful block is defined as motor score of ≤ 2 on modified Bromage scale in the deltoid and bíceps; absent sensation to cold and pinprick sensation in C5 and C6 dermatomes within 30 minutes of injection.

To evaluate phrenic nerve, diaphragmatic excursion will be assessed by ultrasonography of ipsilateral hemidiaphragm and impedance tomography. Pain scores and analgesic consumption will be assessed in PACU.

Moreover, 6 mL of methylene blue will be injected into cadavers to evaluate if dispersion is restricted to fibers of the superior trunk and don't reach phrenic nerve.

研究设计

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

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ASA I or II
  • BMI < 35 kg/m²
  • Patients scheduled for rotator cuff surgery

排除标准

  • cognitive impairment or active psychiatric condition
  • infection at the puncture site of the blockade
  • coagulopathy
  • history of allergy to bupivacaine

研究组 & 干预措施

Bupivacaine - Superior Trunk Block

Experimental

Patients scheduled for rotator cuff surgery received 6 mL of 0,5% bupivacaine in the superior Trunk.

6 mL of methylene blue will be injected into cadavers with the same technique.

干预措施: Bupivacaine - Superior Trunk Block (Procedure)

结局指标

主要结局

Superior Trunk Successful Block

时间窗: within 30 minutes of injection

Evaluate the efficacy of the block: Successful block was defined as motor score of ≤ 2 on modified Bromage scale in the deltoid and bíceps; absent sensation to cold and pinprick sensation in C5 and C6 dermatomes

次要结局

  • Phrenic nerve Block(at 30 minutes)

研究者

发起方
Federal University of São Paulo
申办方类型
Other
责任方
Principal Investigator
主要研究者

Leonardo Henrique Cunha Ferraro

Professor

Federal University of São Paulo

研究点 (2)

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