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

• Sponsor: Federal University of São Paulo (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03512990
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 5.7
• Patients Per Site Per Month: 1.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Brachial Plexus Block; Shoulder Surgery	Procedure: Bupivacaine - Superior Trunk Block	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: 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.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.
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Clinical And Anatomic Study Of An Ultrasound-Guided Selective Block Of The Superior Trunk Of The Brachial Plexus. Description Of A New Approach
• Actual Study Start Date: Apr 9, 2018
• Anticipated Primary Completion Date: Sep 1, 2018
• Anticipated Study Completion Date: Oct 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
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; It will be performed the superior trunk approach with local anesthestic in patients and methylene blue in cadavers.

Outcome Measures

Primary Outcome Measures

1. Superior Trunk Successful Block [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 Outcome Measures

1. Phrenic nerve Block [at 30 minutes]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Federal University of Sao Paulo	Sao Paulo		Brazil	04024002

Sponsors and Collaborators

• Federal University of São Paulo

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Leonardo Henrique Cunha Ferraro, Professor, Federal University of São Paulo
• ClinicalTrials.gov Identifier: NCT03512990
• Other Study ID Numbers: Superior Trunk
• First Posted: May 1, 2018
• Last Update Posted: May 1, 2018
• Last Verified: Apr 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Leonardo Henrique Cunha Ferraro, Professor, Federal University of São Paulo: Brachial Plexus Block; Superior Trunk; Phrenic Nerve
• Additional relevant MeSH terms: Bupivacaine

Study Results

No Results Posted as of May 1, 2018