Determination of the Minimum Effective Volume of Local Anesthetic Using Ultrasound Guidance for Interscalene Brachial Plexus Block
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Anesthesia
- Sponsor
- Federal University of São Paulo
- Enrollment
- 33
- Locations
- 1
- Primary Endpoint
- ED95 of bupivacaine minimum effective volume
- Status
- Completed
- Last Updated
- 13 years ago
Overview
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.
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.
Investigators
Luiz Fernando dos Reis Falcao
Ph.D.
Federal University of São Paulo
Eligibility Criteria
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
Outcomes
Primary Outcomes
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
- Diaphragmatic Function(Diaphragmatic)
- Post-surgery analgesia(Analgesia)