CClinicalTrials.gg
Status unknownNCT03512990Updated May 1, 2018

Clinical And Anatomic Study Of An Ultrasound-Guided Superior Trunk Of The Brachial Plexus

An interventional study of Bupivacaine - Superior Trunk Block in Brachial Plexus Block and Shoulder Surgery, sponsored by Federal University of São Paulo. Status unknown at 1 site in Brazil. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2018-05-01.

Sponsored by Federal University of São Paulo · Not applicable, Interventional, and Basic science

The sponsor has not verified this record recently (last verified Apr 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Brachial Plexus Block
  • Shoulder Surgery

Keywords

  • Brachial Plexus Block
  • Superior Trunk
  • Phrenic Nerve
03

In context

Lead sponsor

Federal University of São Paulo is the lead sponsor of 427 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • cognitive impairment or active psychiatric condition
  • infection at the puncture site of the blockade
  • coagulopathy
  • history of allergy to bupivacaine
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    Bupivacaine - Superior Trunk Block

    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.

    Procedure: Bupivacaine - Superior Trunk Block

Interventions

  • ProcedureBupivacaine - Superior Trunk Block

    It will be performed the superior trunk approach with local anesthestic in patients and methylene blue in cadavers.

06

What researchers measure

Primary outcomes

  1. Superior Trunk Successful Block

    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

    Time frame: within 30 minutes of injection

Secondary outcomes

  1. Phrenic nerve Block

    Evaluate the phrenic function after the block: To evaluate phrenic nerve, diaphragmatic excursion was assessed by ultrasonography of ipsilateral hemidiaphragm

    Time frame: at 30 minutes

07

Study locations

1 of 1 sites recruiting
  • Federal University of Sao Paulo
    Sao Paulo, 04024002, Brazil
    Recruiting
08

References and documents

Publications

  • Franco CD, Williams JM. Ultrasound-Guided Interscalene Block: Reevaluation of the "Stoplight" Sign and Clinical Implications. Reg Anesth Pain Med. 2016 Jul-Aug;41(4):452-9. doi: 10.1097/AAP.0000000000000407. PubMed 27203394 ↗
  • Burckett-St Laurent D, Chan V, Chin KJ. Refining the ultrasound-guided interscalene brachial plexus block: the superior trunk approach. Can J Anaesth. 2014 Dec;61(12):1098-102. doi: 10.1007/s12630-014-0237-3. Epub 2014 Sep 11. PubMed 25208976 ↗
  • Tran DQ, Elgueta MF, Aliste J, Finlayson RJ. Diaphragm-Sparing Nerve Blocks for Shoulder Surgery. Reg Anesth Pain Med. 2017 Jan/Feb;42(1):32-38. doi: 10.1097/AAP.0000000000000529. PubMed 27941477 ↗
  • Franco CD. The Ultrasound Images of the Proximal Interscalene Space: A Reply to Dr Gabriel and Dr Sandhu. Reg Anesth Pain Med. 2017 Jan/Feb;42(1):119-120. doi: 10.1097/AAP.0000000000000533. No abstract available. PubMed 27997487 ↗
  • Siegenthaler A, Moriggl B, Mlekusch S, Schliessbach J, Haug M, Curatolo M, Eichenberger U. Ultrasound-guided suprascapular nerve block, description of a novel supraclavicular approach. Reg Anesth Pain Med. 2012 May-Jun;37(3):325-8. doi: 10.1097/AAP.0b013e3182409168. PubMed 22222688 ↗
  • Wiegel M, Moriggl B, Schwarzkopf P, Petroff D, Reske AW. Anterior Suprascapular Nerve Block Versus Interscalene Brachial Plexus Block for Shoulder Surgery in the Outpatient Setting: A Randomized Controlled Patient- and Assessor-Blinded Trial. Reg Anesth Pain Med. 2017 May/Jun;42(3):310-318. doi: 10.1097/AAP.0000000000000573. PubMed 28257388 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 1, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03512990
Lead sponsor
Federal University of São Paulo
Responsible party
Leonardo Henrique Cunha Ferraro (Professor, Federal University of São Paulo) — Principal investigator
First posted
May 1, 2018
Start date
Apr 9, 2018
Primary completion
Sep 1, 2018 (estimated)
Completion
Oct 1, 2018 (estimated)
Last update
May 1, 2018

Study contacts

Leonardo HC Ferraro, PhD
Contact
leohcferraro@yahoo.com.br
+5511999516103

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

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