NCT02073383

Brief 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 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
313

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2013

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 24, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 27, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

February 27, 2014

Status Verified

February 1, 2014

Enrollment Period

1.3 years

First QC Date

February 24, 2014

Last Update Submit

February 25, 2014

Conditions

Keywords

Axillary brachial plexus blockUltrasoundBupivacaine

Outcome Measures

Primary Outcomes (1)

  • 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

    The primary outcome will be measured at the same day of the procedure.

Secondary Outcomes (1)

  • Block Latency

    30 minutes

Study Arms (3)

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 .

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 .

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 .

Procedure: Axillary brachial plexus block

Interventions

Around ArteryPerineuralTwo injections

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Cognitive impairment or psychiatric disease
  • Active infection condition at the puncture site of the block
  • Bleeding disorders
  • History of allergy to bupivacaine.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of São Paulo

São Paulo, São Paulo, 04024002, Brazil

Location

Related Publications (15)

  • Thompson GE, Rorie DK. Functional anatomy of the brachial plexus sheaths. Anesthesiology. 1983 Aug;59(2):117-22. doi: 10.1097/00000542-198308000-00009.

    PMID: 6869868BACKGROUND
  • Klaastad 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.

    PMID: 12170042BACKGROUND
  • DE JONG RH. Axillary block of the brachial plexus. Anesthesiology. 1961 Mar-Apr;22:215-25. doi: 10.1097/00000542-196103000-00010. No abstract available.

    PMID: 13720553BACKGROUND
  • Vester-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.

    PMID: 6837255BACKGROUND
  • Groban 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.

    PMID: 12567336BACKGROUND
  • Mather 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.

    PMID: 16326341BACKGROUND
  • Fredrickson 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.

    PMID: 19372356BACKGROUND
  • Gautier 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.

    PMID: 21821517BACKGROUND
  • Renes 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.

    PMID: 20975468BACKGROUND
  • Marhofer 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.

    PMID: 9840855BACKGROUND
  • Ponrouch 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.

    PMID: 20705778BACKGROUND
  • Casati 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.

    PMID: 17478453BACKGROUND
  • Riazi 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.

    PMID: 18682410BACKGROUND
  • Bernucci 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.

    PMID: 22660484BACKGROUND
  • Imasogie 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.

    PMID: 20142336BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 24, 2014

First Posted

February 27, 2014

Study Start

August 1, 2013

Primary Completion

December 1, 2014

Study Completion

March 1, 2015

Last Updated

February 27, 2014

Record last verified: 2014-02

Locations