Minimum Effective Volume of Local Anesthetic Using Ultrasound for Brachial Plexus Block

NCT01244932 | Completed Phase 2

• 1 other identifier: UNIFESP-01
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the minimum effective volume of local anesthetic for interscalene brachial plexus block using ultrasound guidance and nerve stimulator guidance.

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

• ED95 of bupivacaine minimum effective volume

  The ED95 of bupivacaine minimum effective volume determination in interscalene brachial plexus block using ultrasound guidance. \[ Time Frame: every 10 minutes until 30 minutes, after 4 hours and after 6 hours post-block \]

  ED95

Secondary Outcomes (2)

• Diaphragmatic Function

  Diaphragmatic

• Post-surgery analgesia

  Analgesia

Interventions

bupivacaine 0.5% DRUG

Patients will be given bupivacaine 0.5% in different doses (up-down study).

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients receiving interscalene brachial plexus block for shoulder surgery
• Age between 21 and 65 years
• ASA physical status I/II
• Body mass index \< 35 kg/m2

You may not qualify if:

• Chronic obstructive pulmonary disease
• Psychiatric history
• Allergy to bupivacaine
• Infection in the site of block
• Coagulation disorders

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

Luiz Fernando dos Reis Falcao

São Paulo, São Paulo, Brazil

Location

Related Publications (10)

• Farquhar-Thomson DR, Baker AK, Satapathy AR, Coventry D, Harper GK, Stafford MA, Hill DA. Minimum volume of local anaesthetic required for an axillary brachial plexus block. Br J Anaesth. 2010 Sep;105(3):382-3. doi: 10.1093/bja/aeq220. No abstract available.

  PMID: 20716568 BACKGROUND

• 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: 20705778 BACKGROUND

• Harper GK, Stafford MA, Hill DA. Minimum volume of local anaesthetic required to surround each of the constituent nerves of the axillary brachial plexus, using ultrasound guidance: a pilot study. Br J Anaesth. 2010 May;104(5):633-6. doi: 10.1093/bja/aeq050. Epub 2010 Mar 16.

  PMID: 20233750 BACKGROUND

• Duggan E, El Beheiry H, Perlas A, Lupu M, Nuica A, Chan VW, Brull R. Minimum effective volume of local anesthetic for ultrasound-guided supraclavicular brachial plexus block. Reg Anesth Pain Med. 2009 May-Jun;34(3):215-8. doi: 10.1097/AAP.0b013e31819a9542.

  PMID: 19587618 BACKGROUND

• O'Donnell BD, Iohom G. An estimation of the minimum effective anesthetic volume of 2% lidocaine in ultrasound-guided axillary brachial plexus block. Anesthesiology. 2009 Jul;111(1):25-9. doi: 10.1097/ALN.0b013e3181a915c7.

  PMID: 19512869 BACKGROUND

• Gupta PK, Pace NL, Hopkins PM. Effect of body mass index on the ED50 volume of bupivacaine 0.5% for supraclavicular brachial plexus block. Br J Anaesth. 2010 Apr;104(4):490-5. doi: 10.1093/bja/aeq017. Epub 2010 Feb 18.

  PMID: 20167584 BACKGROUND

• Marhofer P, Eichenberger U, Stockli S, Huber G, Kapral S, Curatolo M, Kettner S. Ultrasonographic guided axillary plexus blocks with low volumes of local anaesthetics: a crossover volunteer study. Anaesthesia. 2010 Mar;65(3):266-71. doi: 10.1111/j.1365-2044.2010.06247.x. Epub 2010 Jan 29.

  PMID: 20121770 BACKGROUND

• Renes 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.

  PMID: 19920426 BACKGROUND

• Smith HM, Duncan CM, Hebl JR. Clinical utility of low-volume ultrasound-guided interscalene blockade: contraindications reconsidered. J Ultrasound Med. 2009 Sep;28(9):1251-8. doi: 10.7863/jum.2009.28.9.1251.

  PMID: 19710225 BACKGROUND

• Falcao LF, Perez MV, de Castro I, Yamashita AM, Tardelli MA, Amaral JL. Minimum effective volume of 0.5% bupivacaine with epinephrine in ultrasound-guided interscalene brachial plexus block. Br J Anaesth. 2013 Mar;110(3):450-5. doi: 10.1093/bja/aes419. Epub 2012 Nov 29.

  PMID: 23195326 DERIVED

Study Officials

• Luiz Fernando Falcao, MD

  Federal University of São Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D.

Study Record Dates

• First Submitted: October 14, 2010
• First Posted: November 22, 2010
• Study Start: September 1, 2009
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: May 10, 2012

Record last verified: 2012-05

Locations

BR (1)