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

NCT01667315 | Unknown Phase 2

• 1 other identifier: Bupivacaine 0,375%
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Shoulder Surgery

Outcome Measures

Primary Outcomes (1)

• Minimum effective volume of 0,375% bupivacaine

  Minimum effective volume of 0,375% bupivacaine with epinephrine in ultrasound-guided interscalene brachial plexus block for shoulder surgery

  30 minutes

Secondary Outcomes (3)

• Maximum 0,375% bupivacaine volume that maintains the diaphragmatic function

  Before block, 10, 20 and 30 minutes, 4 and 6 hours after

• Pulmonary function

  Before block, 30 minutes, 4 and 6 hours after

• Diaphragmatic Function

  Before block, 30 minutes, 4 and 6 hours after

Study Arms (1)

Bupivacaine

EXPERIMENTAL

Bupivacaine 0,375%

Drug: Bupivacaine 0,375%

Interventions

Bupivacaine 0,375% DRUG

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

Bupivacaine

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

Federal University of Sao Paulo

São Paulo, São Paulo, 04024-002, Brazil

RECRUITING

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 13, 2012
• First Posted: August 17, 2012
• Study Start: August 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: September 1, 2013
• Last Updated: August 17, 2012

Record last verified: 2012-08

Locations

BR (1)