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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2012 by Luiz Fernando Saldanha de Almeida, Federal University of São Paulo.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01667315
First Posted: August 17, 2012
Last Update Posted: August 20, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Luiz Fernando Saldanha de Almeida, Federal University of São Paulo
  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: Intervention Model: Single Group Assignment
Masking: Triple (Participant, 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 Luiz Fernando Saldanha de Almeida, Federal University of São Paulo:

Primary Outcome Measures:
  • Minimum effective volume of 0,375% bupivacaine [ Time Frame: 30 minutes ]
    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 ]
    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 ]
    Spirometric evaluation of forced vital capacity

  • Diaphragmatic Function [ Time Frame: Before block, 30 minutes, 4 and 6 hours after ]
    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

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Ages Eligible for Study:   21 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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%
First Submitted: August 13, 2012
First Posted: August 17, 2012
Last Update Posted: August 20, 2012
Last Verified: August 2012

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