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Completed

NCT Number: NCT01244932

Minimum Effective Volume of Local Anesthetic Using Ultrasound for 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.

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Key information

Conditions

Anesthesia

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Luiz Fernando dos Reis Falcao

São Paulo, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bupivacaine 0.5%

Drug

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

Primary outcomes

  1. 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 ]

Secondary outcomes

  1. 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 ]

  2. Post-surgery analgesia

    Time frame: Analgesia

    Post-surgery analgesia [ Time Frame: after 4 hours and 6 hours post-block ]

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Nov 22, 2010
Registry last updated
May 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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