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Minimum Effective Volume of 0.375% Bupivacaine in Interscalene Brachial Plexus Block

NCT ID: NCT01667315

Last Updated: 2012-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2013-09-30

Brief Summary

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The use of ultrasound in regional anesthesia enables reduction in the local anesthetic volume. The present study aimed to determine the minimum effective volume of 0.375% bupivacaine with epinephrine for interscalene brachial plexus block for shoulder surgery. Following approval by the Research Ethics Committee, patients with a physical condition of I or II according to the American Society of Anesthesiologists, between 21 and 65 years old and subjected to elective surgery of the shoulder and interscalene brachial plexus block will be recruited. The volume of the anesthetic will be determined using a step-up/step-down method and based on the outcome of the preceding block. Positive or negative block results in a 1mL reduction or increase in volume, respectively. The success of the block is defined as the presence of motor block in two muscle groups and the absence of thermal and pain sensations in the necessary dermatomes within 30 minutes of the injection. Diaphragmatic paralysis, pulmonary function and analgesia will be quantified at 30 minutes, 4 and 6 hours. Data will undergo statistical analysis in order to determine minimum effective volume of 0.375% bupivacaine and, secondarily, the maximum volume that maintains the diaphragmatic function, evaluate diaphragm paralysis and its influence in pulmonary function.

Detailed Description

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Conditions

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Shoulder Surgery

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Bupivacaine

Bupivacaine 0,375%

Group Type EXPERIMENTAL

Bupivacaine 0,375%

Intervention Type DRUG

Positive or negative block results in a 1-mL reduction or increase in volume, respectively.

Interventions

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Bupivacaine 0,375%

Positive or negative block results in a 1-mL reduction or increase in volume, respectively.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age between 21 and 65 years
* Candidates for an elective surgical intervention on the shoulder with indication for anesthesia via brachial plexus block
* Physical condition of I or II according to the American Society of Anesthesiologists
* Body mass index up to 35 kg.m-2

Exclusion Criteria

* Chronic obstructive pulmonary disease
* Cognitive impairment or active psychiatric condition
* Infection at the site of the puncture for the block
* Coagulopathy
* Bupivacaine allergy
Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federal University of São Paulo

OTHER

Sponsor Role lead

Responsible Party

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Luiz Fernando Saldanha de Almeida

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Federal University of Sao Paulo

São Paulo, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Facility Contacts

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Luiz Fernando Saldanha de Almeida, MD

Role: primary

Marcelo Vaz Perez, MD PhD

Role: backup

Other Identifiers

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Bupivacaine 0,375%

Identifier Type: -

Identifier Source: org_study_id