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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Federal University of São Paulo.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Luiz Fernando Saldanha de Almeida, Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01667315
First received: August 13, 2012
Last updated: August 16, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Shoulder Surgery
Drug: Bupivacaine 0,375%
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Minimum Effective Volume of 0.375% Bupivacaine in Ultrasound- and Nerve Stimulator-guided Interscalene Brachial Plexus Block for Shoulder Surgery

Resource links provided by NLM:


Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • Minimum effective volume of 0,375% bupivacaine [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    Minimum effective volume of 0,375% bupivacaine with epinephrine in ultrasound-guided interscalene brachial plexus block for shoulder surgery


Secondary Outcome Measures:
  • Maximum 0,375% bupivacaine volume that maintains the diaphragmatic function [ Time Frame: Before block, 10, 20 and 30 minutes, 4 and 6 hours after ] [ Designated as safety issue: No ]
    Maximum effective volume of 0,375% bupivacaine with epinephrine in ultrasound-guided interscalene brachial plexus block for shoulder surgery without diaphragmatic block

  • Pulmonary function [ Time Frame: Before block, 30 minutes, 4 and 6 hours after ] [ Designated as safety issue: No ]
    Spirometric evaluation of forced vital capacity

  • Diaphragmatic Function [ Time Frame: Before block, 30 minutes, 4 and 6 hours after ] [ Designated as safety issue: No ]
    Diaphragmatic movement on ultrasound


Estimated Enrollment: 33
Study Start Date: August 2012
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bupivacaine
Bupivacaine 0,375%
Drug: Bupivacaine 0,375%
Positive or negative block results in a 1-mL reduction or increase in volume, respectively.

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01667315

Locations
Brazil
Federal University of Sao Paulo Recruiting
Sao Paulo, Brazil, 04024-002
Contact: Luiz Fernando Saldanha de Almeida, MD       luizfsa@gmail.com   
Contact: Marcelo Vaz Perez, MD PhD       marcelovazperez@gmail.com   
Sub-Investigator: Marcelo V Perez, MD PhD         
Sponsors and Collaborators
Federal University of São Paulo
  More Information

No publications provided

Responsible Party: Luiz Fernando Saldanha de Almeida, Principal Investigator, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01667315     History of Changes
Other Study ID Numbers: Bupivacaine 0,375%
Study First Received: August 13, 2012
Last Updated: August 16, 2012
Health Authority: Brazil: Ethics Committee

Additional relevant MeSH terms:
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 30, 2014