Three Techniques for Ultrasound Guided Axillary Brachial Plexus Block

February 25, 2014 updated by: Leonardo Henrique Cunha Ferraro, Federal University of São Paulo

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

313

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Sao Paulo
      • São Paulo, Sao Paulo, Brazil, 04024002
        • Federal University of São Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Around Artery

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
Experimental: Two injections
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
Active Comparator: Perineural
Group Perineural : 10 ml of bupivacaine 0.375 % will be injected around the median, ulnar and radial nerves .
Procedure: Axillary brachial plexus block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
The primary outcome will be measured at the same day of the procedure.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Block Latency
Time Frame: 30 minutes
Latency time of the blockade , defined as the time between the end of injection of local anesthetic will be noted.
30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of São Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Anticipated)

December 1, 2014

Study Completion (Anticipated)

March 1, 2015

Study Registration Dates

First Submitted

February 24, 2014

First Submitted That Met QC Criteria

February 25, 2014

First Posted (Estimate)

February 27, 2014

Study Record Updates

Last Update Posted (Estimate)

February 27, 2014

Last Update Submitted That Met QC Criteria

February 25, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FUSaoPaulo - USG Guided Block

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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