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

May 8, 2012 updated by: Luiz Fernando dos Reis Falcao, Federal University of São Paulo

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

33

Phase

  • Phase 2

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
    • SP
      • Sao Paulo, SP, Brazil
        • Luiz Fernando dos Reis Falcao

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

21 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 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: Single Group Assignment
  • Masking: Triple

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ED95 of bupivacaine minimum effective volume
Time Frame: ED95
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diaphragmatic Function
Time Frame: Diaphragmatic
Diaphragmatic Function (as assessed by diaphragmatic movement on ultrasound) [ Time Frame: after 30 minutes, 4 hours and 6 hours post-block ]
Diaphragmatic
Post-surgery analgesia
Time Frame: Analgesia
Post-surgery analgesia [ Time Frame: after 4 hours and 6 hours post-block ]
Analgesia

Collaborators and Investigators

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

Sponsor

Federal University of São Paulo

Investigators

  • Principal Investigator: Luiz Fernando Falcao, MD, 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

September 1, 2009

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

October 14, 2010

First Submitted That Met QC Criteria

November 19, 2010

First Posted (Estimate)

November 22, 2010

Study Record Updates

Last Update Posted (Estimate)

May 10, 2012

Last Update Submitted That Met QC Criteria

May 8, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UNIFESP-01

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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