- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03512990
Clinical And Anatomic Study Of An Ultrasound-Guided Superior Trunk Of The Brachial Plexus
Clinical And Anatomic Study Of An Ultrasound-Guided Selective Block Of The Superior Trunk Of The Brachial Plexus. Description Of A New Approach
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Sao Paulo, Brazil, 04024002
- Recruiting
- Federal University of São Paulo
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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. |
It will be performed the superior trunk approach with local anesthestic in patients and methylene blue in cadavers.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Superior Trunk Successful Block
Time Frame: within 30 minutes of injection
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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
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within 30 minutes of injection
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Phrenic nerve Block
Time Frame: at 30 minutes
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Evaluate the phrenic function after the block: To evaluate phrenic nerve, diaphragmatic excursion was assessed by ultrasonography of ipsilateral hemidiaphragm
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at 30 minutes
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Superior Trunk
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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