<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/NCT01669967</url>
  </required_header>
  <id_info>
    <org_study_id>R11-132</org_study_id>
    <secondary_id>17806</secondary_id>
    <nct_id>NCT01669967</nct_id>
  </id_info>
  <brief_title>The Role of Intravenous (IV) Lidocaine in the Management of Chronic Neuropathic Pain of Peripheral Nerve Origin</brief_title>
  <official_title>The Role of Intravenous (IV) Lidocaine in the Management of Chronic Neuropathic Pain of Peripheral Nerve Origin</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lawson Health Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lawson Health Research Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Pain as a result of nerve injury (neuropathic pain) is a particularly severe form of chronic&#xD;
      pain. Common examples of neuropathic pain are pain due to diabetes and shingles. There is&#xD;
      good evidence that an intravenous infusion of lidocaine (local anesthetic) is useful for the&#xD;
      management of neuropathic pain in the short term - up to six hours.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will examine the role of intravenous lidocaine in the relief of neuropathic pain&#xD;
      over four weeks following infusion compared to an active placebo infusion of&#xD;
      diphenhydramine(Benadryl) in normal saline. If we can show that intravenous lidocaine&#xD;
      provides sustained benefit for up to one month, this will be a major advance in the&#xD;
      management of individuals suffering from neuropathic pain.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2011</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 2015</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>Crossover Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes from Baseline Pain scores on the Visual Analog Scale at 4 weeks</measure>
    <time_frame>every 24 hours for four weeks post-infusion</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hospital Anxiety and Depression Scale</measure>
    <time_frame>obtained baseline, 24 and 72 hours and then weeks 1,2,3, and 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified Brief Pain Inventory</measure>
    <time_frame>obtained baseline, 24, 72 hours and then weeks 1,2,3 and 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Leeds Sleep Evaluation Questionnaire</measure>
    <time_frame>obtained baseline, 24, 72 hours and then weeks 1,2,3 and 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Global Satisfaction with Treatment and Impression of Change</measure>
    <time_frame>obtained baseline, 24, 72 hours and then weeks 1,2,3 and 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Side Effects</measure>
    <time_frame>obtained baseline, 24, 72 hours and then weeks 1,2,3 and 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life Health Outcome Instrument</measure>
    <time_frame>obtained baseline, 24, 72 hours and then weeks 1,2,3 and 4</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">34</enrollment>
  <condition>Neuropathic Pain</condition>
  <arm_group>
    <arm_group_label>Diphenhydramine(Benadryl)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Lidocaine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lidocaine</intervention_name>
    <description>Lidocaine 5 mg/kg in 250 ml of normal saline infused over 45 minutes.</description>
    <arm_group_label>Lidocaine</arm_group_label>
    <other_name>Xylocaine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Diphenhydramine</intervention_name>
    <description>Diphenhydramine 50 mg in 250 ml of normal saline infused over 45 minutes.</description>
    <arm_group_label>Diphenhydramine(Benadryl)</arm_group_label>
    <other_name>Benadryl</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Chronic neuropathic pain due to diabetes mellitus or herpes zoster and a score of 4/10&#xD;
             or greater on the DN4 questionnaire.&#xD;
&#xD;
          -  Moderate to severe pain as defined by screening average pain intensity of 5 or greater&#xD;
             on a 0-10 numerical rating scale.&#xD;
&#xD;
          -  Neuropathic pain duration of at least 6 months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of clinically significant cardiac disease.&#xD;
&#xD;
          -  Poorly controlled seizure disorder.&#xD;
&#xD;
          -  Significant psychiatric disorder.&#xD;
&#xD;
          -  History of allergy to lidocaine or any other amide local anesthetic&#xD;
&#xD;
          -  History of allergy to diphenhydramine.&#xD;
&#xD;
          -  Prior treatment with a local anesthetic infusion.&#xD;
&#xD;
          -  Neuropathic pain due to cancer or complex regional pain syndrome&#xD;
&#xD;
          -  Language barrier or cognitive impairment that would preclude understanding of the&#xD;
             study and filling out of questionnaires&#xD;
&#xD;
          -  Lack of a driver to transport the patient to and from the pain clinic.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dwight Moulin, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Western Ontario, Canada</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>St. Joseph's Health Care</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 4V2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>June 22, 2012</study_first_submitted>
  <study_first_submitted_qc>August 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 21, 2012</study_first_posted>
  <last_update_submitted>March 13, 2019</last_update_submitted>
  <last_update_submitted_qc>March 13, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neuralgia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diphenhydramine</mesh_term>
    <mesh_term>Promethazine</mesh_term>
    <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/NCT01669967
org study id: R11-132
secondary id: 17806
nct id: NCT01669967
lead sponsor: 
has dmc: No
Pain as a result of nerve injury (neuropathic pain) is a particularly severe form of chronic
      pain. Common examples of neuropathic pain are pain due to diabetes and shingles. There is
      good evidence that an intravenous infusion of lidocaine (local anesthetic) is useful for the
      management of neuropathic pain in the short term - up to six hours.
This study will examine the role of intravenous lidocaine in the relief of neuropathic pain
      over four weeks following infusion compared to an active placebo infusion of
      diphenhydramine(Benadryl) in normal saline. If we can show that intravenous lidocaine
      provides sustained benefit for up to one month, this will be a major advance in the
      management of individuals suffering from neuropathic pain.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: Triple (Participant, Care Provider, Investigator)
measure: Changes from Baseline Pain scores on the Visual Analog Scale at 4 weeks
time frame: every 24 hours for four weeks post-infusion
measure: Hospital Anxiety and Depression Scale
time frame: obtained baseline, 24 and 72 hours and then weeks 1,2,3, and 4
measure: Modified Brief Pain Inventory
time frame: obtained baseline, 24, 72 hours and then weeks 1,2,3 and 4
measure: Leeds Sleep Evaluation Questionnaire
time frame: obtained baseline, 24, 72 hours and then weeks 1,2,3 and 4
measure: Patient Global Satisfaction with Treatment and Impression of Change
time frame: obtained baseline, 24, 72 hours and then weeks 1,2,3 and 4
measure: Side Effects
time frame: obtained baseline, 24, 72 hours and then weeks 1,2,3 and 4
measure: Quality of Life Health Outcome Instrument
time frame: obtained baseline, 24, 72 hours and then weeks 1,2,3 and 4
arm group label: Diphenhydramine(Benadryl)
arm group type: Placebo Comparator
arm group label: Lidocaine
arm group type: Active Comparator
intervention type: Drug
intervention name: Lidocaine
description: Lidocaine 5 mg/kg in 250 ml of normal saline infused over 45 minutes.
arm group label: Lidocaine
other name: Xylocaine
intervention type: Drug
intervention name: Diphenhydramine
description: Diphenhydramine 50 mg in 250 ml of normal saline infused over 45 minutes.
arm group label: Diphenhydramine(Benadryl)
other name: Benadryl
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Dwight Moulin, Dr.
role: Principal Investigator
affiliation: University of Western Ontario, Canada
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Neuralgia
mesh term: Diphenhydramine
mesh term: Promethazine
mesh term: Lidocaine