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Clinical Trials/NCT03512990
NCT03512990
Unknown
Not Applicable

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 Paulo1 site in 1 country10 target enrollmentApril 9, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Brachial Plexus Block
Sponsor
Federal University of São Paulo
Enrollment
10
Locations
1
Primary Endpoint
Superior Trunk Successful Block
Last Updated
8 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
April 9, 2018
End Date
October 1, 2018
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Federal University of São Paulo
Responsible Party
Principal Investigator
Principal Investigator

Leonardo Henrique Cunha Ferraro

Professor

Federal University of São Paulo

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Superior Trunk Successful Block

Time Frame: 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

Secondary Outcomes

  • Phrenic nerve Block(at 30 minutes)

Study Sites (1)

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