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

Anesthesia Clinical Trial

Official title:

Determination of the Minimum Effective Volume of Local Anesthetic Using Ultrasound Guidance for Interscalene Brachial Plexus Block

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01244932
• Other study ID #: UNIFESP-01
• Status: Completed
• Phase: Phase 2
• First received: October 14, 2010
• Last updated: May 8, 2012
• Start date: September 2009
• Est. completion date: June 2011

Study information

• Verified date: May 2012
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Description:

This will be a single group assignment, double-blind, up-down sequential allocation study. Interscalene brachial plexus block (ISBPB) is a common nerve block given to patients who are undergoing shoulder surgery. This block has a low, but still significant, rate of complications. Reducing the volume of local anesthetic given during the block may allow some of these complications to be avoided. Participants will undergo ISBPB under ultrasound and nerve stimulator guidance. Patients will initially receive 15mL of local anesthetic (bupivacaine 0.5% with epinephrine). The volume used for each subsequent patient depends upon the success or failure of the previous patient's block - a failure will cause the volume given to increase by 1.0 mL, while a success will cause the volume to decrease by the same amount.

The goal of this study is to determine the minimum effective anesthetic volume of bupivacaine 0.5% providing anesthesia in patients when using ultrasound and nerve stimulator to guide placement of the block. The secondary outcome will be the evaluation of diaphragmatic function and post-surgery analgesia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Chronic obstructive pulmonary disease

• Psychiatric history

• Allergy to bupivacaine

• Infection in the site of block

• Coagulation disorders

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anesthesia

Intervention

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

Locations

Country	Name	City	State
Brazil	Luiz Fernando dos Reis Falcao	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum in: Br J Anaesth. 2010 Sep;105(3):392. Dosage error in article text. — View Citation

Marhofer P, Eichenberger U, Stöckli 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Diaphragmatic Function	Diaphragmatic Function (as assessed by diaphragmatic movement on ultrasound) [ Time Frame: after 30 minutes, 4 hours and 6 hours post-block ]	Diaphragmatic	No
Secondary	Post-surgery analgesia	Post-surgery analgesia [ Time Frame: after 4 hours and 6 hours post-block ]	Analgesia	No