<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/NCT02192411</url>
  </required_header>
  <id_info>
    <org_study_id>JVDL070714</org_study_id>
    <nct_id>NCT02192411</nct_id>
  </id_info>
  <brief_title>Efficacy of Variable Lidocaine Concentrations in Tumescent Anesthesia for Pain Control During and After Endovenous Laser Procedure; Non-inferiority Trial</brief_title>
  <official_title>Efficacy of Variable Lidocaine Concentrations in Tumescent Anesthesia for Pain Control During and After Endovenous Laser Procedure; a Double Blinded, Randomized, Controlled Non-inferiority Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Midwest Vein Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Midwest Vein Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Endovenous laser treatment is a minimally invasive procedure that has been shown to be a safe&#xD;
      and effective treatment for varicose veins. Essential to the successful ablation of refluxing&#xD;
      veins by endovenous laser treatment is the use of tumescent anesthesia. One of the components&#xD;
      of tumescent anesthesia is lidocaine, a commonly used local anesthetic. While lidocaine can&#xD;
      be used safely as long as serum concentrations remain low, its use carries the risk of&#xD;
      lidocaine toxicity. In order to minimize the risk of lidocaine toxicity it is desirable to&#xD;
      use the minimum effective concentration of lidocaine needed to manage pain during a&#xD;
      procedure. This study seeks to determine if a ¼ lower concentration of lidocaine in tumescent&#xD;
      anesthesia will function as well as the standard dose for pain management in endovenous laser&#xD;
      treatments. If we find that this is the case, we will be able to reduce the risk of lidocaine&#xD;
      toxicity in patients undergoing endovenous laser treatment, while maintaining their comfort&#xD;
      throughout the procedure. This will be achieved through a direct comparison of intra- and&#xD;
      post-operative pain for patients randomized to receive either the ¼ tumescent lidocaine&#xD;
      concentration or the standard lidocaine concentration.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>July 2014</start_date>
  <primary_completion_date type="Anticipated">December 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain</measure>
    <time_frame>24 hours</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">70</enrollment>
  <condition>Pain During and After Endovenous Laser Obliteration of Large Saphenous Vein Based on Lidocaine Tumescent Concentration</condition>
  <arm_group>
    <arm_group_label>Standard Lidocaine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>50mL 1% lidocaine in 450mL normal saline</description>
  </arm_group>
  <arm_group>
    <arm_group_label>1/4 dose lidocaine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>12.5mL 1% lidocaine in 487.5mL normal saline</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lidocaine</intervention_name>
    <description>1/4 dose lidocaine</description>
    <arm_group_label>1/4 dose lidocaine</arm_group_label>
    <arm_group_label>Standard Lidocaine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Large Saphenous Vein treatment&#xD;
&#xD;
          -  16-85 years old, good health&#xD;
&#xD;
          -  Able to understand informed consent&#xD;
&#xD;
          -  Eligible for EVLT determined by physician&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with know lidocaine sensitivity&#xD;
&#xD;
          -  Bleeding disorders&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Congestive heart failure&#xD;
&#xD;
          -  Liver dysfunction&#xD;
&#xD;
          -  Patient ineligible for EVLT&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Deborah S Lindner, MD</last_name>
    <phone>3127183051</phone>
    <email>deborahsuemd@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jelena Vasic</last_name>
    <phone>5203498998</phone>
    <email>jelena.vasic@northwestern.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Midwest Vein Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
    <investigator>
      <last_name>Deborah S Lindner, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 14, 2014</study_first_submitted>
  <study_first_submitted_qc>July 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 16, 2014</study_first_posted>
  <last_update_submitted>July 15, 2014</last_update_submitted>
  <last_update_submitted_qc>July 15, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 16, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Midwest Vein Center</investigator_affiliation>
    <investigator_full_name>Deborah Lindner, MD</investigator_full_name>
    <investigator_title>Principle Investigator</investigator_title>
  </responsible_party>
  <keyword>lidocaine</keyword>
  <keyword>tumescent</keyword>
  <keyword>endovenous</keyword>
  <keyword>laser</keyword>
  <keyword>pain</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lidocaine</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/NCT02192411
org study id: JVDL070714
nct id: NCT02192411
lead sponsor: 
has dmc: Yes
Endovenous laser treatment is a minimally invasive procedure that has been shown to be a safe
      and effective treatment for varicose veins. Essential to the successful ablation of refluxing
      veins by endovenous laser treatment is the use of tumescent anesthesia. One of the components
      of tumescent anesthesia is lidocaine, a commonly used local anesthetic. While lidocaine can
      be used safely as long as serum concentrations remain low, its use carries the risk of
      lidocaine toxicity. In order to minimize the risk of lidocaine toxicity it is desirable to
      use the minimum effective concentration of lidocaine needed to manage pain during a
      procedure. This study seeks to determine if a ¼ lower concentration of lidocaine in tumescent
      anesthesia will function as well as the standard dose for pain management in endovenous laser
      treatments. If we find that this is the case, we will be able to reduce the risk of lidocaine
      toxicity in patients undergoing endovenous laser treatment, while maintaining their comfort
      throughout the procedure. This will be achieved through a direct comparison of intra- and
      post-operative pain for patients randomized to receive either the ¼ tumescent lidocaine
      concentration or the standard lidocaine concentration.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Care Provider)
measure: Pain
time frame: 24 hours
arm group label: Standard Lidocaine
arm group type: Active Comparator
description: 50mL 1% lidocaine in 450mL normal saline
arm group label: 1/4 dose lidocaine
arm group type: Experimental
description: 12.5mL 1% lidocaine in 487.5mL normal saline
intervention type: Drug
intervention name: Lidocaine
description: 1/4 dose lidocaine
arm group label: 1/4 dose lidocaine
arm group label: Standard Lidocaine
criteria: 
gender: All
minimum age: 16 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Deborah S Lindner, MD
phone: 3127183051
email: deborahsuemd@gmail.com
last name: Jelena Vasic
phone: 5203498998
email: jelena.vasic@northwestern.edu
facility: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Midwest Vein Center
investigator full name: Deborah Lindner, MD
investigator title: Principle Investigator
mesh term: Lidocaine