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

June 24, 2018 updated by: Leonardo Henrique Cunha Ferraro, Federal University of São Paulo

Evaluation of Variation of Ventilation and Pulmonary Aeration Using Electrical Impedance Tomography in Patients With Interscalene Brachial Plexus Block for Shoulder Surgery

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

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, Brazil, 04024-002
        • Recruiting
        • Federal University of São Paulo
        • Principal Investigator:
          • Leonardo HC Ferraro, M.D.
      • Sao Paulo, Brazil, 04024002
        • Recruiting
        • Federal University of Sao Paulo - Hospital Sao Paulo
        • Contact:

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 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

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: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Bupivacaine 4ml
The interscalene brachial plexus block is performed with 4ml at level of C5-6 roots
Drug: Bupivacaine 4 mL
The interscalene brachial plexus block is performed with 4ml of bupivacaine-epinephrine 0,5%- 1:200,000
ACTIVE_COMPARATOR: Bupivacaine 15ml
The interscalene brachial plexus block is performed with 15ml at level of C5-6
Drug: Bupivacaine 15 mL
The interscalene brachial plexus block is performed with 15ml of bupivacaine-epinephrine 0,5%- 1:200,000

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Variation of pulmonary function
Time Frame: 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.
4 hour

Secondary Outcome Measures

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

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: Leonardo HC Ferraro, PhD, 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 (ACTUAL)

May 17, 2018

Primary Completion (ANTICIPATED)

October 17, 2018

Study Completion (ANTICIPATED)

December 17, 2018

Study Registration Dates

First Submitted

June 6, 2018

First Submitted That Met QC Criteria

June 24, 2018

First Posted (ACTUAL)

July 5, 2018

Study Record Updates

Last Update Posted (ACTUAL)

July 5, 2018

Last Update Submitted That Met QC Criteria

June 24, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 48739315.4.0000.5505

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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