Hand SurgeryNCT02073383
Three Techniques for Ultrasound Guided Axillary Brachial Plexus Block
A study testing Axillary brachial plexus block in people with Hand Surgery, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
The brachial plexus block is an anesthetic technique often used for surgical procedures of the upper limb. The brachial plexus block through the axilla (BPVA) is one of the techniques most commonly used to obtain regional anesthesia of the upper limbs, being performed by anesthesia of the terminal branches of the… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hand Surgery
- What is being tested?
- Axillary brachial plexus block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 313 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2013to Mar 2015
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent signed by the patient (IC)
- Indication for brachial plexus block for anesthesia and analgesia in candidates for hand surgical procedures
- ASA physical status I, II or III according to the American Association of Anesthesiology.
Who cannot join
- Cognitive impairment or psychiatric disease
- Active infection condition at the puncture site of the block
- Bleeding disorders
- History of allergy to bupivacaine.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Randomized Study of Three Different Techniques for Ultrasound Guided Axillary Brachial Plexus Block
The brachial plexus block is an anesthetic technique often used for surgical procedures of the upper limb. The brachial plexus block through the axilla (BPVA) is one of the techniques most commonly used to obtain regional anesthesia of the upper limbs, being performed by anesthesia of the terminal branches of the brachial plexus, which would be the ulnar, median, radial and musculocutaneous nerves. With the aid of ultrasound , two techniques can be used to perform the BPVA . The first , known as multiple puncture technique , the local anesthetic is deposited around each nerve that want to block . This technique is most commonly used to perform the BPVA . The second technique , known as 2 injections , local anesthetic is deposited below the axillary artery and around the musculocutaneous nerve . This technique has been proposed to try to reduce the execution time of anesthesia . Studies actually show that the technique of 2 injections showed less time to perform the block, with the same success rate. However, the technique of 2 injections showed a longer latency and higher rate of vascular puncture . (14) In order to perform a procedure with shorter execution time , without changing the latency, success rate and ensuring patient safety , the investigators designed this protocol to evaluate three techniques for performing the ultrasound- guided axillary brachial plexus block.
- Conditions
- Hand Surgery
- Being tested
- Axillary brachial plexus block
- Keywords
- Axillary brachial plexus block, Ultrasound, Bupivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Axillary brachial plexus blockProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Around Artery | Experimental | Intervention Name: Axillary brachial plexus block
Group A: 30 ml of 0.375% bupivacaine will be injected around the artery . If this were a clock, would deposit 7,5 ml of anesthetic in positions 0, 3, 6 and 9 . Receives: Procedure: Axillary brachial plexus block |
| Two injections | Experimental | Group 2: 30 ml of bupivacaine 0.375 % below the artery will be injected in the 6 o'clock position . Receives: Procedure: Axillary brachial plexus block |
| Perineural | Active comparator | Group Perineural : 10 ml of bupivacaine 0.375 % will be injected around the median, ulnar and radial nerves . Receives: Procedure: Axillary brachial plexus block |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is to compare the efficacy of the three different techniques for ultrasound guided axillary brachial plexus block
The brachial plexus block is performed through the axilla , with the aid of ultrasound and a peripheral nerve stimulator with the patient in the supine position. The needle that will be used is 22G x 50 mm . After disinfection and skin antisepsis with chlorhexidine , tha puncture site will be infiltrated with 1% lidocaine . Furthermore, musculocutaneous nerve will be blockade with 10 ml of 0.375% bupivacaine for all patients. Patients will be divided into three groups :
Group A: 30 ml of 0.375% bupivacaine will be injected around the artery . If this were a clock, would deposit 7,5 ml of anesthetic in positions 0, 3, 6 and 9 .
Group 2 injections : 30 ml of bupivacaine 0.375 % below the artery will be injected in the 6 o'clock position .
Group M : 10 ml of bupivacaine 0.375 % will be injected
Measured: The primary outcome will be measured at the same day of the procedure.
Secondary outcomes (1)
Block Latency
Latency time of the blockade , defined as the time between the end of injection of local anesthetic will be noted.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2014 (estimated)
- Study startAug 2013
- Primary completionDec 2014 (estimated)
- Study completionMar 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Hand SurgeryStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 313 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
- NCT02073383
- Sponsor's protocol ID
- FUSaoPaulo - USG Guided Block
- Status last verified
- Feb 2014
- First submitted
- 24 Feb 2014
- Last updated
- 27 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Thompson GE, Rorie DK. Functional anatomy of the brachial plexus sheaths. Anesthesiology. 1983 Aug;59(2):117-22. doi: 10.1097/00000542-198308000-00009.
PubMed 6869868Klaastad O, Smedby O, Thompson GE, Tillung T, Hol PK, Rotnes JS, Brodal P, Breivik H, Hetland KR, Fosse ET. Distribution of local anesthetic in axillary brachial plexus block: a clinical and magnetic resonance imaging study. Anesthesiology. 2002 Jun;96(6):1315-24. doi: 10.1097/00000542-200206000-00009.
PubMed 12170042DE JONG RH. Axillary block of the brachial plexus. Anesthesiology. 1961 Mar-Apr;22:215-25. doi: 10.1097/00000542-196103000-00010. No abstract available.
PubMed 13720553Vester-Andersen T, Christiansen C, Sorensen M, Kaalund-Jorgensen HO, Saugbjerg P, Schultz-Moller K. Perivascular axillary block II: influence of injected volume of local anaesthetic on neural blockade. Acta Anaesthesiol Scand. 1983 Apr;27(2):95-8. doi: 10.1111/j.1399-6576.1983.tb01913.x.
PubMed 6837255Groban L. Central nervous system and cardiac effects from long-acting amide local anesthetic toxicity in the intact animal model. Reg Anesth Pain Med. 2003 Jan-Feb;28(1):3-11. doi: 10.1053/rapm.2003.50014.
PubMed 12567336Mather LE, Copeland SE, Ladd LA. Acute toxicity of local anesthetics: underlying pharmacokinetic and pharmacodynamic concepts. Reg Anesth Pain Med. 2005 Nov-Dec;30(6):553-66. doi: 10.1016/j.rapm.2005.07.186.
PubMed 16326341Fredrickson MJ, Ball CM, Dalgleish AJ, Stewart AW, Short TG. A prospective randomized comparison of ultrasound and neurostimulation as needle end points for interscalene catheter placement. Anesth Analg. 2009 May;108(5):1695-700. doi: 10.1213/ane.0b013e31819c29b8.
PubMed 19372356Gautier 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 21821517Renes 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 20975468Marhofer P, Schrogendorfer K, Wallner T, Koinig H, Mayer N, Kapral S. Ultrasonographic guidance reduces the amount of local anesthetic for 3-in-1 blocks. Reg Anesth Pain Med. 1998 Nov-Dec;23(6):584-8. doi: 10.1016/s1098-7339(98)90086-4.
PubMed 9840855Ponrouch M, Bouic N, Bringuier S, Biboulet P, Choquet O, Kassim M, Bernard N, Capdevila X. Estimation and pharmacodynamic consequences of the minimum effective anesthetic volumes for median and ulnar nerve blocks: a randomized, double-blind, controlled comparison between ultrasound and nerve stimulation guidance. Anesth Analg. 2010 Oct;111(4):1059-64. doi: 10.1213/ANE.0b013e3181eb6372. Epub 2010 Aug 12.
PubMed 20705778Casati A, Baciarello M, Di Cianni S, Danelli G, De Marco G, Leone S, Rossi M, Fanelli G. Effects of ultrasound guidance on the minimum effective anaesthetic volume required to block the femoral nerve. Br J Anaesth. 2007 Jun;98(6):823-7. doi: 10.1093/bja/aem100. Epub 2007 May 3.
PubMed 17478453Riazi 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 18682410Bernucci F, Gonzalez AP, Finlayson RJ, Tran DQ. A prospective, randomized comparison between perivascular and perineural ultrasound-guided axillary brachial plexus block. Reg Anesth Pain Med. 2012 Sep-Oct;37(5):473-7. doi: 10.1097/AAP.0b013e3182576b6f.
PubMed 22660484Imasogie N, Ganapathy S, Singh S, Armstrong K, Armstrong P. A prospective, randomized, double-blind comparison of ultrasound-guided axillary brachial plexus blocks using 2 versus 4 injections. Anesth Analg. 2010 Apr 1;110(4):1222-6. doi: 10.1213/ANE.0b013e3181cb6791. Epub 2010 Feb 8.
PubMed 20142336
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Study of Three Different Techniques for Ultrasound Guided Axillary Brachial Plexus Block
- ClinicalTrials.gov ID
- NCT02073383
- Acronym / sponsor ID
- FUSaoPaulo - USG Guided Block
- Conditions
- Hand Surgery
- Keywords
- Axillary brachial plexus block, Ultrasound, Bupivacaine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 313 participants (estimated)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Mar 2015 (estimated)
- First posted
- 27 Feb 2014 (estimated)
- 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.
The brachial plexus block is an anesthetic technique often used for surgical procedures of the upper limb. The brachial plexus block through the axilla (BPVA) is one of the techniques most commonly used to obtain regional anesthesia of the upper limbs, being performed by anesthesia of the terminal branches of the brachial plexus, which would be the ulnar, median, radial and musculocutaneous nerves. With the aid of ultrasound , two techniques can be used to perform the BPVA . The first , known as multiple puncture technique , the local anesthetic is deposited around each nerve that want to block . This technique is most commonly used to perform the BPVA . The second technique , known as 2 injections , local anesthetic is deposited below the axillary artery and around the musculocutaneous nerve . This technique has been proposed to try to reduce the execution time of anesthesia . Studies actually show that the technique of 2 injections showed less time to perform the block, with the same success rate. However, the technique of 2 injections showed a longer latency and higher rate of vascular puncture . (14) In order to perform a procedure with shorter execution time , without changing the latency, success rate and ensuring patient safety , the investigators designed this protocol to evaluate three techniques for performing the ultrasound- guided axillary brachial plexus block.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Around Artery | Experimental | Procedure: Axillary brachial plexus blockIntervention Name: Axillary brachial plexus block Group A: 30 ml of 0.375% bupivacaine will be injected around the artery . If this were a clock, would deposit 7,5 ml of anesthetic in positions 0, 3, 6 and 9 . |
| Two injections | Experimental | Procedure: Axillary brachial plexus blockGroup 2: 30 ml of bupivacaine 0.375 % below the artery will be injected in the 6 o'clock position . |
| Perineural | Active comparator | Procedure: Axillary brachial plexus blockGroup Perineural : 10 ml of bupivacaine 0.375 % will be injected around the median, ulnar and radial nerves . |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Informed consent signed by the patient (IC)
- Indication for brachial plexus block for anesthesia and analgesia in candidates for hand surgical procedures
- ASA physical status I, II or III according to the American Association of Anesthesiology.
Key exclusion criteria (4 listed)
- Cognitive impairment or psychiatric disease
- Active infection condition at the puncture site of the block
- Bleeding disorders
- 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 |
|---|---|---|
| Axillary brachial plexus block | Procedure or surgery | Around Artery, Perineural, Two injections |
Primary outcome
The primary outcome is to compare the efficacy of the three different techniques for ultrasound guided axillary brachial plexus block
Time frame: The primary outcome will be measured at the same day of the procedure.
The brachial plexus block is performed through the axilla , with the aid of ultrasound and a peripheral nerve stimulator with the patient in the supine position. The needle that will be used is 22G x 50 mm . After disinfection and skin antisepsis with chlorhexidine , tha puncture site will be infiltrated with 1% lidocaine . Furthermore, musculocutaneous nerve will be blockade with 10 ml of 0.375% bupivacaine for all patients. Patients will be divided into three groups : Group A: 30 ml of 0.375% bupivacaine will be injected around the artery . If this were a clock, would deposit 7,5 ml of anesthetic in positions 0, 3, 6 and 9 . Group 2 injections : 30 ml of bupivacaine 0.375 % below the artery will be injected in the 6 o'clock position . Group M : 10 ml of bupivacaine 0.375 % will be injected
1 secondary outcome
Block Latency
Time frame: 30 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2014.
- Background: PubMed 6869868Thompson GE, Rorie DK. Functional anatomy of the brachial plexus sheaths. Anesthesiology. 1983 Aug;59(2):117-22. doi: 10.1097/00000542-198308000-00009.
- Background: PubMed 12170042Klaastad O, Smedby O, Thompson GE, Tillung T, Hol PK, Rotnes JS, Brodal P, Breivik H, Hetland KR, Fosse ET. Distribution of local anesthetic in axillary brachial plexus block: a clinical and magnetic resonance imaging study. Anesthesiology. 2002 Jun;96(6):1315-24. doi: 10.1097/00000542-200206000-00009.
- Background: PubMed 13720553DE JONG RH. Axillary block of the brachial plexus. Anesthesiology. 1961 Mar-Apr;22:215-25. doi: 10.1097/00000542-196103000-00010. No abstract available.
- Background: PubMed 6837255Vester-Andersen T, Christiansen C, Sorensen M, Kaalund-Jorgensen HO, Saugbjerg P, Schultz-Moller K. Perivascular axillary block II: influence of injected volume of local anaesthetic on neural blockade. Acta Anaesthesiol Scand. 1983 Apr;27(2):95-8. doi: 10.1111/j.1399-6576.1983.tb01913.x.
- Background: PubMed 12567336Groban L. Central nervous system and cardiac effects from long-acting amide local anesthetic toxicity in the intact animal model. Reg Anesth Pain Med. 2003 Jan-Feb;28(1):3-11. doi: 10.1053/rapm.2003.50014.
- Background: PubMed 16326341Mather LE, Copeland SE, Ladd LA. Acute toxicity of local anesthetics: underlying pharmacokinetic and pharmacodynamic concepts. Reg Anesth Pain Med. 2005 Nov-Dec;30(6):553-66. doi: 10.1016/j.rapm.2005.07.186.
- Background: PubMed 19372356Fredrickson MJ, Ball CM, Dalgleish AJ, Stewart AW, Short TG. A prospective randomized comparison of ultrasound and neurostimulation as needle end points for interscalene catheter placement. Anesth Analg. 2009 May;108(5):1695-700. doi: 10.1213/ane.0b013e31819c29b8.
- Background: 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.
- Background: 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.
- Background: PubMed 9840855Marhofer P, Schrogendorfer K, Wallner T, Koinig H, Mayer N, Kapral S. Ultrasonographic guidance reduces the amount of local anesthetic for 3-in-1 blocks. Reg Anesth Pain Med. 1998 Nov-Dec;23(6):584-8. doi: 10.1016/s1098-7339(98)90086-4.
- Background: PubMed 20705778Ponrouch M, Bouic N, Bringuier S, Biboulet P, Choquet O, Kassim M, Bernard N, Capdevila X. Estimation and pharmacodynamic consequences of the minimum effective anesthetic volumes for median and ulnar nerve blocks: a randomized, double-blind, controlled comparison between ultrasound and nerve stimulation guidance. Anesth Analg. 2010 Oct;111(4):1059-64. doi: 10.1213/ANE.0b013e3181eb6372. Epub 2010 Aug 12.
- Background: PubMed 17478453Casati A, Baciarello M, Di Cianni S, Danelli G, De Marco G, Leone S, Rossi M, Fanelli G. Effects of ultrasound guidance on the minimum effective anaesthetic volume required to block the femoral nerve. Br J Anaesth. 2007 Jun;98(6):823-7. doi: 10.1093/bja/aem100. Epub 2007 May 3.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Axillary brachial plexus block in people with Hand 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 27 Feb 2014. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome is to compare the efficacy of the three different techniques for ultrasound guided axillary brachial plexus block (time frame: The primary outcome will be measured at the same day of the procedure.). 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 NCT02073383, which also lists 15 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 27 Feb 2014.