Ventilation and Pulmonary Aeration, Electrical Impedance Tomography, Interscalene Brachial Plexus Block

Not Applicable

• Conditions: Pulmonary Ventilation; Brachial Plexus Block
• Interventions: Drug: Bupivacaine 4 mL; Drug: Bupivacaine 15 mL

• Registration Number: NCT03577860
• Lead Sponsor: Federal University of São Paulo

Brief Summary

Patients with indication of shoulder surgery will be submitted to ultrasound-guided interscalene brachial plexus block with 4ml or 15ml of bupivacaine- epinephrine 0,5%- 1:200,000 at level of C5-6 roots and will be evaluated their ventilation and pulmonary aeration by electrical impedance tomography

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-17
• Status Verified: 2018-06
• Study First Submitted: 2018-06-06
• Study First Submitted QC: 2018-06-24
• Last Update Submitted: 2018-06-24
• Study First Posted: 2018-07-05
• Last Update Posted: 2018-07-05
• Primary Completion: 2018-10-17
• Study Completion: 2018-12-17

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• shoulder surgery
• indication of interscalene brachial plexus block
• American Society of Anesthesiology Physical Status Classification I or II

Exclusion criteria:

• refuse to participate
• previous lung or diaphragma surgeries

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bupivacaine 4ml	Bupivacaine 4 mL	The interscalene brachial plexus block is performed with 4ml at level of C5-6 roots
Bupivacaine 15ml	Bupivacaine 15 mL	The interscalene brachial plexus block is performed with 15ml at level of C5-6

Primary Outcome Measures

Name	Time	Method
Variation of pulmonary function	4 hour	Evaluation of variation of pulmonary aeration and ventilation after interscalene brachial plexus block with 4ml or 15 ml of bupivacaine- epinephrine 0,5%1:200,0000. The pulmonary function will be evaluated by electrical impedance tomography.

Secondary Outcome Measures

Name	Time	Method
Opioid consumption	24 hours	Opioid consumption (Tramal - mg) will be recorded during the first 24 hours.
Post-Operative pain	24 hours	The post operative pain will be evaluated using Visual Analog Score for pain during the first 24 hours.

Trial Locations

Locations (2)

Federal University of Sao Paulo - Hospital Sao Paulo; 🇧🇷 Sao Paulo, Brazil

Federal University of Sao Paulo; 🇧🇷 Sao Paulo, Brazil