<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01667315</url>
  </required_header>
  <id_info>
    <org_study_id>Bupivacaine 0,375%</org_study_id>
    <nct_id>NCT01667315</nct_id>
  </id_info>
  <brief_title>Minimum Effective Volume of 0.375% Bupivacaine in Interscalene Brachial Plexus Block</brief_title>
  <official_title>Minimum Effective Volume of 0.375% Bupivacaine in Ultrasound- and Nerve Stimulator-guided Interscalene Brachial Plexus Block for Shoulder Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federal University of São Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Federal University of São Paulo</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The use of ultrasound in regional anesthesia enables reduction in the local anesthetic&#xD;
      volume. The present study aimed to determine the minimum effective volume of 0.375%&#xD;
      bupivacaine with epinephrine for interscalene brachial plexus block for shoulder surgery.&#xD;
      Following approval by the Research Ethics Committee, patients with a physical condition of I&#xD;
      or II according to the American Society of Anesthesiologists, between 21 and 65 years old and&#xD;
      subjected to elective surgery of the shoulder and interscalene brachial plexus block will be&#xD;
      recruited. The volume of the anesthetic will be determined using a step-up/step-down method&#xD;
      and based on the outcome of the preceding block. Positive or negative block results in a 1mL&#xD;
      reduction or increase in volume, respectively. The success of the block is defined as the&#xD;
      presence of motor block in two muscle groups and the absence of thermal and pain sensations&#xD;
      in the necessary dermatomes within 30 minutes of the injection. Diaphragmatic paralysis,&#xD;
      pulmonary function and analgesia will be quantified at 30 minutes, 4 and 6 hours. Data will&#xD;
      undergo statistical analysis in order to determine minimum effective volume of 0.375%&#xD;
      bupivacaine and, secondarily, the maximum volume that maintains the diaphragmatic function,&#xD;
      evaluate diaphragm paralysis and its influence in pulmonary function.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>August 2012</start_date>
  <completion_date type="Anticipated">September 2013</completion_date>
  <primary_completion_date type="Anticipated">January 2013</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Minimum effective volume of 0,375% bupivacaine</measure>
    <time_frame>30 minutes</time_frame>
    <description>Minimum effective volume of 0,375% bupivacaine with epinephrine in ultrasound-guided interscalene brachial plexus block for shoulder surgery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maximum 0,375% bupivacaine volume that maintains the diaphragmatic function</measure>
    <time_frame>Before block, 10, 20 and 30 minutes, 4 and 6 hours after</time_frame>
    <description>Maximum effective volume of 0,375% bupivacaine with epinephrine in ultrasound-guided interscalene brachial plexus block for shoulder surgery without diaphragmatic block</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pulmonary function</measure>
    <time_frame>Before block, 30 minutes, 4 and 6 hours after</time_frame>
    <description>Spirometric evaluation of forced vital capacity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diaphragmatic Function</measure>
    <time_frame>Before block, 30 minutes, 4 and 6 hours after</time_frame>
    <description>Diaphragmatic movement on ultrasound</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">33</enrollment>
  <condition>Shoulder Surgery</condition>
  <arm_group>
    <arm_group_label>Bupivacaine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Bupivacaine 0,375%</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupivacaine 0,375%</intervention_name>
    <description>Positive or negative block results in a 1-mL reduction or increase in volume, respectively.</description>
    <arm_group_label>Bupivacaine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age between 21 and 65 years&#xD;
&#xD;
          -  Candidates for an elective surgical intervention on the shoulder with indication for&#xD;
             anesthesia via brachial plexus block&#xD;
&#xD;
          -  Physical condition of I or II according to the American Society of Anesthesiologists&#xD;
&#xD;
          -  Body mass index up to 35 kg.m-2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Chronic obstructive pulmonary disease&#xD;
&#xD;
          -  Cognitive impairment or active psychiatric condition&#xD;
&#xD;
          -  Infection at the site of the puncture for the block&#xD;
&#xD;
          -  Coagulopathy&#xD;
&#xD;
          -  Bupivacaine allergy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Federal University of Sao Paulo</name>
      <address>
        <city>Sao Paulo</city>
        <zip>04024-002</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Luiz Fernando Saldanha de Almeida, MD</last_name>
      <email>luizfsa@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Marcelo Vaz Perez, MD PhD</last_name>
      <email>marcelovazperez@gmail.com</email>
    </contact_backup>
    <investigator>
      <last_name>Marcelo V Perez, MD PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 13, 2012</study_first_submitted>
  <study_first_submitted_qc>August 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 17, 2012</study_first_posted>
  <last_update_submitted>August 16, 2012</last_update_submitted>
  <last_update_submitted_qc>August 16, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 17, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Federal University of São Paulo</investigator_affiliation>
    <investigator_full_name>Luiz Fernando Saldanha de Almeida</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bupivacaine</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01667315
org study id: Bupivacaine 0,375%
nct id: NCT01667315
lead sponsor: 
has dmc: No
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Minimum effective volume of 0,375% bupivacaine
time frame: 30 minutes
description: Minimum effective volume of 0,375% bupivacaine with epinephrine in ultrasound-guided interscalene brachial plexus block for shoulder surgery
measure: Maximum 0,375% bupivacaine volume that maintains the diaphragmatic function
time frame: Before block, 10, 20 and 30 minutes, 4 and 6 hours after
description: Maximum effective volume of 0,375% bupivacaine with epinephrine in ultrasound-guided interscalene brachial plexus block for shoulder surgery without diaphragmatic block
measure: Pulmonary function
time frame: Before block, 30 minutes, 4 and 6 hours after
description: Spirometric evaluation of forced vital capacity
measure: Diaphragmatic Function
time frame: Before block, 30 minutes, 4 and 6 hours after
description: Diaphragmatic movement on ultrasound
arm group label: Bupivacaine
arm group type: Experimental
description: Bupivacaine 0,375%
intervention type: Drug
intervention name: Bupivacaine 0,375%
description: Positive or negative block results in a 1-mL reduction or increase in volume, respectively.
arm group label: Bupivacaine
criteria: 
gender: All
minimum age: 21 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Federal University of São Paulo
investigator full name: Luiz Fernando Saldanha de Almeida
investigator title: Principal Investigator
mesh term: Bupivacaine