Brachial Plexus BlockNCT03512990
Clinical And Anatomic Study Of An Ultrasound-Guided Superior Trunk Of The Brachial Plexus
A study testing Bupivacaine - Superior Trunk Block in people with Brachial Plexus Block and Shoulder Surgery, run by Federal University of São Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Brachial Plexus Block, Shoulder Surgery
- What is being tested?
- Bupivacaine - Superior Trunk Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBrazil
- Study dates
- 9 Apr 2018to 1 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I or II
- BMI < 35 kg/m²
- Patients scheduled for rotator cuff surgery
Who cannot join
- cognitive impairment or active psychiatric condition
- infection at the puncture site of the blockade
- coagulopathy
- history of allergy to bupivacaine
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Federal University of Sao Paulo
São Paulo, 04024002
Leonardo HC Ferraro, PhD, +5511999516103, leohcferraro@yahoo.com.br
About this study
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
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.
Read more
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
- Being tested
- Bupivacaine - Superior Trunk Block
- Keywords
- Brachial Plexus Block, Superior Trunk, Phrenic Nerve
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine - Superior Trunk BlockProcedure or surgery
It will be performed the superior trunk approach with local anesthestic in patients and methylene blue in cadavers.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Bupivacaine - Superior Trunk Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: at 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2018
- Study start9 Apr 2018
- Primary completion1 Sep 2018 (estimated)
- Study completion1 Oct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Brachial Plexus BlockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leonardo Henrique Cunha Ferraro, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03512990
- Sponsor's protocol ID
- Superior Trunk
- Status last verified
- Apr 2018
- First submitted
- 10 Apr 2018
- Last updated
- 1 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 27203394Burckett-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 25208976Tran 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 27941477Franco 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 27997487Siegenthaler 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 22222688Wiegel 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
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03512990
- Acronym / sponsor ID
- Superior Trunk
- Conditions
- Brachial Plexus Block, Shoulder Surgery
- Keywords
- Brachial Plexus Block, Superior Trunk, Phrenic Nerve
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- 9 Apr 2018 (actual)
- Primary completion
- 1 Sep 2018 (estimated)
- Study completion
- 1 Oct 2018 (estimated)
- First posted
- 1 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine - Superior Trunk Block | Experimental | Procedure: Bupivacaine - Superior Trunk BlockPatients 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA I or II
- BMI < 35 kg/m²
- Patients scheduled for rotator cuff surgery
Key exclusion criteria (4 listed)
- cognitive impairment or active psychiatric condition
- infection at the puncture site of the blockade
- coagulopathy
- history of allergy to bupivacaine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bupivacaine - Superior Trunk BlockIt will be performed the superior trunk approach with local anesthestic in patients and methylene blue in cadavers. | Procedure or surgery | Bupivacaine - Superior Trunk Block |
Primary outcome
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
1 secondary outcome
Phrenic nerve Block
Time frame: at 30 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2018.
- Results publication: PubMed 27203394Franco 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.
- Results publication: PubMed 25208976Burckett-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.
- Results publication: PubMed 27941477Tran 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.
- Results publication: PubMed 27997487Franco 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.
- Results publication: PubMed 22222688Siegenthaler 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.
- Results publication: PubMed 28257388Wiegel 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.
- Individual participant dataSharing planned: No
Related trials for Brachial Plexus Block
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bupivacaine - Superior Trunk Block in people with Brachial Plexus Block and Shoulder Surgery, run by Federal University of São Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Leonardo HC Ferraro, PhD (+5511999516103, leohcferraro@yahoo.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Superior Trunk Successful Block (time frame: within 30 minutes of injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03512990, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2018.