Brachial Plexus BlockNCT03577860
Ventilation and Pulmonary Aeration, Electrical Impedance Tomography, Interscalene Brachial Plexus Block
A study testing Bupivacaine 4 mL and Bupivacaine 15 mL in people with Brachial Plexus Block and Pulmonary Ventilation, run by Federal University of São Paulo at 2 sites in Brazil.
Trial summary
Patients with indication of shoulder surgery will be submitted to ultrasound-guided interscalene brachial plexus block with 4ml or 15ml of bupivacaine- epinephrine 0,5%- 1:200,000 at level of C5-6 roots and will be evaluated their ventilation and pulmonary aeration by electrical impedance tomography Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Brachial Plexus Block, Pulmonary Ventilation
- What is being tested?
- Bupivacaine 4 mL and Bupivacaine 15 mL
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesBrazil
- Study dates
- 17 May 2018to 17 Dec 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- shoulder surgery
- indication of interscalene brachial plexus block
- American Society of Anesthesiology Physical Status Classification I or II
Who cannot join
- refuse to participate
- previous lung or diaphragma surgeries
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites, 2 recruiting
- Recruiting
Federal University of Sao Paulo
São Paulo, 04024-002
Leonardo HC Ferraro, M.D.
- Recruiting
Federal University of Sao Paulo - Hospital Sao Paulo
São Paulo, 04024002
Leonardo HC Ferraro, MD, +5511999516103, leohcferraro@yahoo.com.br
About this study
Official title: Evaluation of Variation of Ventilation and Pulmonary Aeration Using Electrical Impedance Tomography in Patients With Interscalene Brachial Plexus Block for Shoulder Surgery
Patients with indication of shoulder surgery will be submitted to ultrasound-guided interscalene brachial plexus block with 4ml or 15ml of bupivacaine- epinephrine 0,5%- 1:200,000 at level of C5-6 roots and will be evaluated their ventilation and pulmonary aeration by electrical impedance tomography
- Conditions
- Brachial Plexus Block, Pulmonary Ventilation
- Being tested
- Bupivacaine 4 mL, Bupivacaine 15 mL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine 4 mLDrug
The interscalene brachial plexus block is performed with 4ml of bupivacaine-epinephrine 0,5%- 1:200,000
Bupivacaine 15 mLDrug
The interscalene brachial plexus block is performed with 15ml of bupivacaine-epinephrine 0,5%- 1:200,000
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine 4ml | Active comparator | The interscalene brachial plexus block is performed with 4ml at level of C5-6 roots Receives: Drug: Bupivacaine 4 mL |
| Bupivacaine 15ml | Active comparator | The interscalene brachial plexus block is performed with 15ml at level of C5-6 Receives: Drug: Bupivacaine 15 mL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation of pulmonary function
Evaluation of variation of pulmonary aeration and ventilation after interscalene brachial plexus block with 4ml or 15 ml of bupivacaine- epinephrine 0,5%1:200,0000. The pulmonary function will be evaluated by electrical impedance tomography.
Measured: 4 hour
Secondary outcomes (2)
Opioid consumption
Opioid consumption (Tramal - mg) will be recorded during the first 24 hours.
Measured: 24 hours
Post-Operative pain
The post operative pain will be evaluated using Visual Analog Score for pain during the first 24 hours.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2018
- Study start17 May 2018
- Primary completion17 Oct 2018 (estimated)
- Study completion17 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 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
- Investigators
- Leonardo HC Ferraro, PhD, Principal investigator, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03577860
- Sponsor's protocol ID
- 48739315.4.0000.5505
- Status last verified
- Jun 2018
- First submitted
- 6 Jun 2018
- Last updated
- 5 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sinha SK, Abrams JH, Weller RS. Ultrasound-guided interscalene needle placement produces successful anesthesia regardless of motor stimulation above or below 0.5 mA. Anesth Analg. 2007 Sep;105(3):848-52. doi: 10.1213/01.ane.0000271912.84440.01.
PubMed 17717249Riazi S, Carmichael N, Awad I, Holtby RM, McCartney CJ. Effect of local anaesthetic volume (20 vs 5 ml) on the efficacy and respiratory consequences of ultrasound-guided interscalene brachial plexus block. Br J Anaesth. 2008 Oct;101(4):549-56. doi: 10.1093/bja/aen229. Epub 2008 Aug 4.
PubMed 18682410Gautier P, Vandepitte C, Ramquet C, DeCoopman M, Xu D, Hadzic A. The minimum effective anesthetic volume of 0.75% ropivacaine in ultrasound-guided interscalene brachial plexus block. Anesth Analg. 2011 Oct;113(4):951-5. doi: 10.1213/ANE.0b013e31822b876f. Epub 2011 Aug 4.
PubMed 21821517Urmey WF, Talts KH, Sharrock NE. One hundred percent incidence of hemidiaphragmatic paresis associated with interscalene brachial plexus anesthesia as diagnosed by ultrasonography. Anesth Analg. 1991 Apr;72(4):498-503. doi: 10.1213/00000539-199104000-00014.
PubMed 2006740Urmey WF, McDonald M. Hemidiaphragmatic paresis during interscalene brachial plexus block: effects on pulmonary function and chest wall mechanics. Anesth Analg. 1992 Mar;74(3):352-7. doi: 10.1213/00000539-199203000-00006.
PubMed 1539813Renes SH, van Geffen GJ, Rettig HC, Gielen MJ, Scheffer GJ. Minimum effective volume of local anesthetic for shoulder analgesia by ultrasound-guided block at root C7 with assessment of pulmonary function. Reg Anesth Pain Med. 2010 Nov-Dec;35(6):529-34. doi: 10.1097/AAP.0b013e3181fa1190.
PubMed 20975468Urmey WF, Gloeggler PJ. Pulmonary function changes during interscalene brachial plexus block: effects of decreasing local anesthetic injection volume. Reg Anesth. 1993 Jul-Aug;18(4):244-9.
PubMed 8398959Gottardis M, Luger T, Florl C, Schon G, Penz T, Resch H, Benzer A. Spirometry, blood gas analysis and ultrasonography of the diaphragm after Winnie's interscalene brachial plexus block. Eur J Anaesthesiol. 1993 Sep;10(5):367-9.
PubMed 11767428Hortense A, Perez MV, Amaral JL, Oshiro AC, Rossetti HB. Interscalene brachial plexus block. Effects on pulmonary function. Rev Bras Anestesiol. 2010 Mar-Apr;60(2):130-7, 74-8. doi: 10.1016/s0034-7094(10)70017-9. English, Portuguese, Spanish.
PubMed 20485957Renes SH, Rettig HC, Gielen MJ, Wilder-Smith OH, van Geffen GJ. Ultrasound-guided low-dose interscalene brachial plexus block reduces the incidence of hemidiaphragmatic paresis. Reg Anesth Pain Med. 2009 Sep-Oct;34(5):498-502. doi: 10.1097/AAP.0b013e3181b49256.
PubMed 19920426
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Variation of Ventilation and Pulmonary Aeration Using Electrical Impedance Tomography in Patients With Interscalene Brachial Plexus Block for Shoulder Surgery
- ClinicalTrials.gov ID
- NCT03577860
- Acronym / sponsor ID
- 48739315.4.0000.5505
- Conditions
- Brachial Plexus Block, Pulmonary Ventilation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- 17 May 2018 (actual)
- Primary completion
- 17 Oct 2018 (estimated)
- Study completion
- 17 Dec 2018 (estimated)
- First posted
- 5 Jul 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.
Patients with indication of shoulder surgery will be submitted to ultrasound-guided interscalene brachial plexus block with 4ml or 15ml of bupivacaine- epinephrine 0,5%- 1:200,000 at level of C5-6 roots and will be evaluated their ventilation and pulmonary aeration by electrical impedance tomography
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine 4ml | Active comparator | Drug: Bupivacaine 4 mLThe interscalene brachial plexus block is performed with 4ml at level of C5-6 roots |
| Bupivacaine 15ml | Active comparator | Drug: Bupivacaine 15 mLThe interscalene brachial plexus block is performed with 15ml at level of C5-6 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- shoulder surgery
- indication of interscalene brachial plexus block
- American Society of Anesthesiology Physical Status Classification I or II
Key exclusion criteria (2 listed)
- refuse to participate
- previous lung or diaphragma surgeries
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 4 mLThe interscalene brachial plexus block is performed with 4ml of bupivacaine-epinephrine 0,5%- 1:200,000 | Drug | Bupivacaine 4ml |
| Bupivacaine 15 mLThe interscalene brachial plexus block is performed with 15ml of bupivacaine-epinephrine 0,5%- 1:200,000 | Drug | Bupivacaine 15ml |
Primary outcome
Variation of pulmonary function
Time frame: 4 hour
Evaluation of variation of pulmonary aeration and ventilation after interscalene brachial plexus block with 4ml or 15 ml of bupivacaine- epinephrine 0,5%1:200,0000. The pulmonary function will be evaluated by electrical impedance tomography.
2 secondary outcomes
Opioid consumption
Time frame: 24 hours
Post-Operative pain
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2018.
- Results publication: PubMed 17717249Sinha SK, Abrams JH, Weller RS. Ultrasound-guided interscalene needle placement produces successful anesthesia regardless of motor stimulation above or below 0.5 mA. Anesth Analg. 2007 Sep;105(3):848-52. doi: 10.1213/01.ane.0000271912.84440.01.
- Results publication: PubMed 18682410Riazi S, Carmichael N, Awad I, Holtby RM, McCartney CJ. Effect of local anaesthetic volume (20 vs 5 ml) on the efficacy and respiratory consequences of ultrasound-guided interscalene brachial plexus block. Br J Anaesth. 2008 Oct;101(4):549-56. doi: 10.1093/bja/aen229. Epub 2008 Aug 4.
- Results publication: PubMed 21821517Gautier P, Vandepitte C, Ramquet C, DeCoopman M, Xu D, Hadzic A. The minimum effective anesthetic volume of 0.75% ropivacaine in ultrasound-guided interscalene brachial plexus block. Anesth Analg. 2011 Oct;113(4):951-5. doi: 10.1213/ANE.0b013e31822b876f. Epub 2011 Aug 4.
- Results publication: PubMed 2006740Urmey WF, Talts KH, Sharrock NE. One hundred percent incidence of hemidiaphragmatic paresis associated with interscalene brachial plexus anesthesia as diagnosed by ultrasonography. Anesth Analg. 1991 Apr;72(4):498-503. doi: 10.1213/00000539-199104000-00014.
- Results publication: PubMed 1539813Urmey WF, McDonald M. Hemidiaphragmatic paresis during interscalene brachial plexus block: effects on pulmonary function and chest wall mechanics. Anesth Analg. 1992 Mar;74(3):352-7. doi: 10.1213/00000539-199203000-00006.
- Results publication: PubMed 20975468Renes SH, van Geffen GJ, Rettig HC, Gielen MJ, Scheffer GJ. Minimum effective volume of local anesthetic for shoulder analgesia by ultrasound-guided block at root C7 with assessment of pulmonary function. Reg Anesth Pain Med. 2010 Nov-Dec;35(6):529-34. doi: 10.1097/AAP.0b013e3181fa1190.
- Results publication: PubMed 8398959Urmey WF, Gloeggler PJ. Pulmonary function changes during interscalene brachial plexus block: effects of decreasing local anesthetic injection volume. Reg Anesth. 1993 Jul-Aug;18(4):244-9.
- Results publication: PubMed 11767428Gottardis M, Luger T, Florl C, Schon G, Penz T, Resch H, Benzer A. Spirometry, blood gas analysis and ultrasonography of the diaphragm after Winnie's interscalene brachial plexus block. Eur J Anaesthesiol. 1993 Sep;10(5):367-9.
- Results publication: PubMed 20485957Hortense A, Perez MV, Amaral JL, Oshiro AC, Rossetti HB. Interscalene brachial plexus block. Effects on pulmonary function. Rev Bras Anestesiol. 2010 Mar-Apr;60(2):130-7, 74-8. doi: 10.1016/s0034-7094(10)70017-9. English, Portuguese, Spanish.
- Results publication: PubMed 19920426Renes SH, Rettig HC, Gielen MJ, Wilder-Smith OH, van Geffen GJ. Ultrasound-guided low-dose interscalene brachial plexus block reduces the incidence of hemidiaphragmatic paresis. Reg Anesth Pain Med. 2009 Sep-Oct;34(5):498-502. doi: 10.1097/AAP.0b013e3181b49256.
- Individual participant dataSharing planned: No
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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.
Leonardo HC Ferraro, PhD principal investigator
Federal University of São Paulo
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bupivacaine 4 mL and Bupivacaine 15 mL in people with Brachial Plexus Block and Pulmonary Ventilation, run by Federal University of São Paulo at 2 sites 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 2 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 5 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Variation of pulmonary function (time frame: 4 hour). 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 NCT03577860, which also lists 10 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 5 Jul 2018.