<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/NCT01703130</url>
  </required_header>
  <id_info>
    <org_study_id>126-2012</org_study_id>
    <nct_id>NCT01703130</nct_id>
  </id_info>
  <brief_title>Determining the Minimal Effective Volume (MEAV95) for Interscalene Brachial Plexus Block for Surgical Anesthesia</brief_title>
  <acronym>MEAV 95</acronym>
  <official_title>Determining the Minimal Effective Volume (MEAV95) for Interscalene Brachial Plexus Block for Surgical Anesthesia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sunnybrook Health Sciences Centre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Physicians' Services Incorporated Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Sunnybrook Health Sciences Centre</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Interscalene block (ISB) consistently demonstrates superior pain relief after shoulder&#xD;
      surgery. However, patients can experience complications such as blurred vision, hoarseness&#xD;
      and shortness of breath with the standard volumes of local anesthetic used in contemporary&#xD;
      practice. Patients with respiratory diseases are precluded because of the potential effects&#xD;
      on respiration. However, they are then exposed to the risks of general anesthesia and opioid&#xD;
      medications which can also have detrimental effects on respiration. Ultrasound guided ISB can&#xD;
      reduce the local anesthetic volume required to produce anesthesia for shoulder surgery; this&#xD;
      may reduce the complications from ISB to allow patients previously unable to benefit to have&#xD;
      this technique, such as patients with obesity and respiratory disease. In order to do so the&#xD;
      investigators will use an up-down methodology to find the minimum volume of local anesthetic&#xD;
      to provide sufficient anesthesia for shoulder surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2012</start_date>
  <completion_date type="Anticipated">December 2014</completion_date>
  <primary_completion_date type="Anticipated">December 2014</primary_completion_date>
  <phase>Phase 4</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>MEAV95 of ropivacaine 0.75%</measure>
    <time_frame>30 minutes post injection</time_frame>
    <description>to determine the MEAV95 of ropivacaine 0.75% at the level of root C5-6 using the dose-finding protocol. The success of surgical anesthesia is defined by the presence of sensory blockade (no sensation/score of 0 to pinprick testing) 30 minutes post injection of local anesthetic</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Motor blockade</measure>
    <time_frame>30 minutes</time_frame>
    <description>The C5 myotome covers the deltoid muscle (the most powerful motion being shoulder abduction) and the biceps brachii muscle. Biceps brachii is also innervated by C6. Therefore, motor blockade will be assessed by testing shoulder abduction and forearm flexion. Motor function will be classified as present (any movement) or absent (no movement)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bedside spirometry</measure>
    <time_frame>30 minutes post block, 30min post-surgery, and 2 hours post surgery</time_frame>
    <description>Bedside spirometry (FEV1, FVC, PEFR) and Pulse oximetry on air: at baseline, 30 minutes post block, 30min post-surgery, and 2 hours post surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diaphragmatic excursion</measure>
    <time_frame>30 minutes post block, and 2 hours post surgery</time_frame>
    <description>Diaphragmatic excursion: ultrasound examination at baseline, 30 minutes post block, and 2 hours post surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications</measure>
    <time_frame>30 minutes</time_frame>
    <description>Complications: Hoarseness, Horner's syndrome, intravascular injection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Scores on Visual Analog Scale</measure>
    <time_frame>at baseline, after surgery at 30 and 60 minutes in the PACU, and at 1 hour intervals until discharge</time_frame>
    <description>Visual analog scale (VAS) - at baseline, after surgery at 30 and 60 minutes in the PACU, and at 1 hour intervals until discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total opioid consumption until discharge</measure>
    <time_frame>24 hours (at discharge)</time_frame>
    <description>Total opioid consumption until discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Opioid related side effects</measure>
    <time_frame>24 hours (at discharge)</time_frame>
    <description>Opioid related side effects: nausea, vomiting, dizziness, pruritis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to first analgesic use</measure>
    <time_frame>within 24 hours post surgery</time_frame>
    <description>Time to first analgesic use in hospital and after discharge</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Shoulder Pain</condition>
  <arm_group>
    <arm_group_label>Local Anesthestic Dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Dose of of ropivacaine 0.75% used in block procedure</intervention_name>
    <arm_group_label>Local Anesthestic Dose</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing elective arthroscopic shoulder surgery in the sitting position&#xD;
&#xD;
          -  Patients aged &gt;=18 and &lt;=75 years&#xD;
&#xD;
          -  ASA I-III&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient refusal for surgery under ISBPB with sedation&#xD;
&#xD;
          -  Lack of capacity to provide informed consent&#xD;
&#xD;
          -  Pre-existing COPD, unstable asthma or diaphragmatic dysfunction&#xD;
&#xD;
          -  Coagulopathy&#xD;
&#xD;
          -  Infection at injection site&#xD;
&#xD;
          -  Allergy to local anesthetics&#xD;
&#xD;
          -  Opioid tolerance (&gt;30mg oral morphine or equivalent/day for &gt;1 week)&#xD;
&#xD;
          -  BMI&gt;40&#xD;
&#xD;
          -  Inability to complete questionnaires and assessments (consent, follow-up phone call)&#xD;
             due to language barrier&#xD;
&#xD;
          -  Pregnancy or lactation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Colin McCartney</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sunnybrook Health Sciences Centre</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Stephen Choi</last_name>
    <role>Study Chair</role>
    <affiliation>Sunnybrook Health Sciences Centre</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jane Wang</last_name>
    <role>Study Chair</role>
    <affiliation>Sunnybrook Health Sciences Centre</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Moein Tavakkoli Zadeh</last_name>
    <role>Study Chair</role>
    <affiliation>Sunnybrook Health Sciences Centre</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Colin McCartney</last_name>
    <phone>(416) 480-6100</phone>
    <email>colin.mccartney@sunnybrook.ca</email>
  </overall_contact>
  <location>
    <facility>
      <name>Sunnybrook Health Sciences Centre - Holland Orthopaedic and Arthritic Centre</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M4Y 1H1</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Colin McCartney</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <link>
    <url>http://sunnybrook.ca/research/</url>
    <description>Facility website</description>
  </link>
  <verification_date>May 2014</verification_date>
  <study_first_submitted>October 4, 2012</study_first_submitted>
  <study_first_submitted_qc>October 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 10, 2012</study_first_posted>
  <last_update_submitted>May 29, 2014</last_update_submitted>
  <last_update_submitted_qc>May 29, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 2, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sunnybrook Health Sciences Centre</investigator_affiliation>
    <investigator_full_name>Dr. Colin McCartney</investigator_full_name>
    <investigator_title>Staff Anesthesiologist and Director of Research</investigator_title>
  </responsible_party>
  <keyword>ISPB</keyword>
  <keyword>Brachial Plexus Block</keyword>
  <keyword>Anesthesia</keyword>
  <keyword>Pain Management</keyword>
  <keyword>Surgery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Shoulder Pain</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ropivacaine</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/NCT01703130
org study id: 126-2012
nct id: NCT01703130
lead sponsor: 
collaborator: 
has dmc: Yes
Interscalene block (ISB) consistently demonstrates superior pain relief after shoulder
      surgery. However, patients can experience complications such as blurred vision, hoarseness
      and shortness of breath with the standard volumes of local anesthetic used in contemporary
      practice. Patients with respiratory diseases are precluded because of the potential effects
      on respiration. However, they are then exposed to the risks of general anesthesia and opioid
      medications which can also have detrimental effects on respiration. Ultrasound guided ISB can
      reduce the local anesthetic volume required to produce anesthesia for shoulder surgery; this
      may reduce the complications from ISB to allow patients previously unable to benefit to have
      this technique, such as patients with obesity and respiratory disease. In order to do so the
      investigators will use an up-down methodology to find the minimum volume of local anesthetic
      to provide sufficient anesthesia for shoulder surgery.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: MEAV95 of ropivacaine 0.75%
time frame: 30 minutes post injection
description: to determine the MEAV95 of ropivacaine 0.75% at the level of root C5-6 using the dose-finding protocol. The success of surgical anesthesia is defined by the presence of sensory blockade (no sensation/score of 0 to pinprick testing) 30 minutes post injection of local anesthetic
measure: Motor blockade
time frame: 30 minutes
description: The C5 myotome covers the deltoid muscle (the most powerful motion being shoulder abduction) and the biceps brachii muscle. Biceps brachii is also innervated by C6. Therefore, motor blockade will be assessed by testing shoulder abduction and forearm flexion. Motor function will be classified as present (any movement) or absent (no movement)
measure: Bedside spirometry
time frame: 30 minutes post block, 30min post-surgery, and 2 hours post surgery
description: Bedside spirometry (FEV1, FVC, PEFR) and Pulse oximetry on air: at baseline, 30 minutes post block, 30min post-surgery, and 2 hours post surgery
measure: Diaphragmatic excursion
time frame: 30 minutes post block, and 2 hours post surgery
description: Diaphragmatic excursion: ultrasound examination at baseline, 30 minutes post block, and 2 hours post surgery
measure: Complications
time frame: 30 minutes
description: Complications: Hoarseness, Horner's syndrome, intravascular injection
measure: Pain Scores on Visual Analog Scale
time frame: at baseline, after surgery at 30 and 60 minutes in the PACU, and at 1 hour intervals until discharge
description: Visual analog scale (VAS) - at baseline, after surgery at 30 and 60 minutes in the PACU, and at 1 hour intervals until discharge
measure: Total opioid consumption until discharge
time frame: 24 hours (at discharge)
description: Total opioid consumption until discharge
measure: Opioid related side effects
time frame: 24 hours (at discharge)
description: Opioid related side effects: nausea, vomiting, dizziness, pruritis
measure: Time to first analgesic use
time frame: within 24 hours post surgery
description: Time to first analgesic use in hospital and after discharge
arm group label: Local Anesthestic Dose
arm group type: Experimental
intervention type: Procedure
intervention name: Dose of of ropivacaine 0.75% used in block procedure
arm group label: Local Anesthestic Dose
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Colin McCartney
role: Principal Investigator
affiliation: Sunnybrook Health Sciences Centre
last name: Stephen Choi
role: Study Chair
affiliation: Sunnybrook Health Sciences Centre
last name: Jane Wang
role: Study Chair
affiliation: Sunnybrook Health Sciences Centre
last name: Moein Tavakkoli Zadeh
role: Study Chair
affiliation: Sunnybrook Health Sciences Centre
last name: Colin McCartney
phone: (416) 480-6100
email: colin.mccartney@sunnybrook.ca
facility: 
status: Recruiting
investigator: 
country: Canada
url: http://sunnybrook.ca/research/
description: Facility website
responsible party type: Principal Investigator
investigator affiliation: Sunnybrook Health Sciences Centre
investigator full name: Dr. Colin McCartney
investigator title: Staff Anesthesiologist and Director of Research
mesh term: Shoulder Pain
mesh term: Ropivacaine