Minimum Effective Volume of 0.375% Bupivacaine in Interscalene Brachial Plexus Block
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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 |
- 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
- 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 |
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| 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 | |
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 May 21, 2013