<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/NCT01716078</url>
  </required_header>
  <id_info>
    <org_study_id>365681-8</org_study_id>
    <nct_id>NCT01716078</nct_id>
  </id_info>
  <brief_title>The Effect of Brachial Plexus Nerve Block on Distal Peripheral Nerve Conduction</brief_title>
  <official_title>The Effect of Brachial Plexus Nerve Block on Distal Peripheral Nerve Conduction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Defense and Veterans Center for Integrative Pain Management</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Defense and Veterans Center for Integrative Pain Management</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the conducting ability of distal extremity nerves&#xD;
      after a supraclavicular brachial plexus nerve block (with local anesthetic) has been placed&#xD;
      at a more proximal location in the upper extremity.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <start_date>November 2011</start_date>
  <primary_completion_date type="Actual">September 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Compund Muscle Action Potential (CMAP) amplitude</measure>
    <time_frame>1 day</time_frame>
    <description>measured for motor studies from baseline to peak in mV</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Distal Latency</measure>
    <time_frame>1 day</time_frame>
    <description>the interval between the stimulation of a compound muscle and the observed response. Normal nerve conduction velocity is above 40 m/sec in the lower extremities and above 50 m/sec in the upper extremities, but age, muscle disease, temperature, and other factors can influence the velocity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peak Latency</measure>
    <time_frame>1 day</time_frame>
    <description>This represents conduction along the majority of the axons&#xD;
It is recorded at the peak of the waveform response</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Onset Latency</measure>
    <time_frame>1 day</time_frame>
    <description>This represents conduction along the fastest axons&#xD;
It is recorded at the initial deflection from baseline</description>
  </secondary_outcome>
  <enrollment type="Actual">0</enrollment>
  <condition>Anesthesia</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Male and female military health care beneficiaries age 18 years and older presenting for&#xD;
        hand surgery and eligible for a brachial plexus nerve block will be asked to participate in&#xD;
        this study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female military health care beneficiaries 18 years and older, capable of&#xD;
             providing informed consent indicating awareness of the investigational nature of the&#xD;
             study, in keeping with institutional policy&#xD;
&#xD;
          -  Written informed consent must be obtained from each patient prior to entering the&#xD;
             study&#xD;
&#xD;
          -  Patients must be willing to have a regional anesthetic nerve block placed prior to&#xD;
             their scheduled procedure&#xD;
&#xD;
          -  Patients must be willing to have neurodiagnostic tests performed prior to placement&#xD;
             and after placement of the regional anesthesia nerve block&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refusal to have a brachial plexus nerve block placed&#xD;
&#xD;
          -  Refusal to have serial nerve conduction studies performed&#xD;
&#xD;
          -  Contraindication for a regional anesthesia nerve block (allergy to local anesthetic,&#xD;
             infection at site of injection, elevated coagulation time)&#xD;
&#xD;
          -  Presence of conditions affecting the hand or arm (e.g., injury, infection) that might&#xD;
             preclude the performance of nerve conduction studies&#xD;
&#xD;
          -  Presence of known major abnormalities of nerve conduction, e.g., absent median sensory&#xD;
             potential in a patient scheduled for carpal tunnel release&#xD;
&#xD;
          -  Presence of conditions affecting the contralateral hand or arm (e.g., injury,&#xD;
             infection) that might preclude the performance of sensory and motor studies to test&#xD;
             block or absence of a contralateral upper extremity&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Fort Meade</name>
      <address>
        <city>Fort Meade</city>
        <state>Maryland</state>
        <zip>20755</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2016</verification_date>
  <study_first_submitted>October 17, 2012</study_first_submitted>
  <study_first_submitted_qc>October 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 29, 2012</study_first_posted>
  <last_update_submitted>January 28, 2016</last_update_submitted>
  <last_update_submitted_qc>January 28, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 29, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Brachial Plexus</keyword>
  <keyword>Nerve Block</keyword>
  <keyword>Nerve Conduction</keyword>
  <!-- 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/NCT01716078
org study id: 365681-8
nct id: NCT01716078
lead sponsor: 
has dmc: No
The purpose of this study is to determine the conducting ability of distal extremity nerves
      after a supraclavicular brachial plexus nerve block (with local anesthetic) has been placed
      at a more proximal location in the upper extremity.
observational model: Cohort
time perspective: Prospective
measure: Compund Muscle Action Potential (CMAP) amplitude
time frame: 1 day
description: measured for motor studies from baseline to peak in mV
measure: Distal Latency
time frame: 1 day
description: the interval between the stimulation of a compound muscle and the observed response. Normal nerve conduction velocity is above 40 m/sec in the lower extremities and above 50 m/sec in the upper extremities, but age, muscle disease, temperature, and other factors can influence the velocity.
measure: Peak Latency
time frame: 1 day
description: This represents conduction along the majority of the axons
It is recorded at the peak of the waveform response
measure: Onset Latency
time frame: 1 day
description: This represents conduction along the fastest axons
It is recorded at the initial deflection from baseline
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor