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

NCT03512990 | Unknown DMC

• 1 other identifier: Superior Trunk
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Brachial Plexus Block; Shoulder Surgery

Keywords

Brachial Plexus Block; Superior Trunk; Phrenic Nerve

Outcome Measures

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

  within 30 minutes of injection

Secondary Outcomes (1)

• Phrenic nerve Block

  at 30 minutes

Study Arms (1)

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.

Procedure: Bupivacaine - Superior Trunk Block

Interventions

Bupivacaine - Superior Trunk Block PROCEDURE

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

Bupivacaine - Superior Trunk Block

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

Federal University of Sao Paulo

São Paulo, 04024002, Brazil

RECRUITING

Related Publications (6)

• 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.

  PMID: 27203394 RESULT

• 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.

  PMID: 25208976 RESULT

• 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.

  PMID: 27941477 RESULT

• 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.

  PMID: 27997487 RESULT

• 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.

  PMID: 22222688 RESULT

• 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.

  PMID: 28257388 RESULT

Central Study Contacts

Leonardo HC Ferraro, PhD

CONTACT

+5511999516103; leohcferraro@yahoo.com.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: We 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. Patients scheduled for rotator cuff surgery will receive 6 mL of 0,5% bupivacaine. 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 with impedance tomography. Moreover, 6 mL of methylene blue will be injected into cadavers to evaluate if dispersion was restricted to fibers of the superior trunk and don't reach phrenic nerve.

Study Record Dates

• First Submitted: April 10, 2018
• First Posted: May 1, 2018
• Study Start: April 9, 2018
• Primary Completion: September 1, 2018
• Study Completion: October 1, 2018
• Last Updated: May 1, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)