<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/NCT02217267</url>
  </required_header>
  <id_info>
    <org_study_id>SI140/2014</org_study_id>
    <nct_id>NCT02217267</nct_id>
  </id_info>
  <brief_title>Long Term Outcome After Serial Lidocaine Infusion in Peripheral Neuropathic Pain</brief_title>
  <official_title>Long Term Outcome After Serial Lidocaine Infusion in Peripheral Neuropathic Pain : A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mahidol University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mahidol University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study to evaluated Long term outcome after serial Lidocaine infusion when&#xD;
      compared with placebo in peripheral neuropathic pain patients in acute stage (less than 6&#xD;
      months) at 3 months after first time of infusion&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Peripheral nerve injury may give rise to severe and long-lasting types of pains which are&#xD;
      often resistant to treatment such as opioid, tricyclic antidepressant or anticonvulsant.&#xD;
      Lidocaine infusion has been the one of intractable neuropathic pain treatment . My hypothesis&#xD;
      the serial lidocaine infusion can adequate pain control and can prevent chronic pain (central&#xD;
      sensitisation). Therefore, we designed this prospective, randomised, double-blind, controlled&#xD;
      study to evaluate the efficacy of serial lidocaine infusion in peripheral neuropathic pain&#xD;
      compared with placebo in long term outcome (at 3 month).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 1, 2014</start_date>
  <completion_date type="Actual">February 2018</completion_date>
  <primary_completion_date type="Actual">December 29, 2017</primary_completion_date>
  <phase>Phase 3</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain intensity</measure>
    <time_frame>at 3 months after serial lidocaine infusion</time_frame>
    <description>Pain intensity (Numerical Rating Scale; from 0-10) 0 means no pain, and 10 means worst pain imaginable.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of life using Utility score</measure>
    <time_frame>at 3 month after serial lidocaine infusion</time_frame>
    <description>Quality of life will be assessed using EuroQol5D5L and reported as a utility score (0-1.0) &quot;0&quot; represents death, and &quot;0.1&quot; means full health</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Psychological effects on depression, anxiety and stress</measure>
    <time_frame>at 3 month after serial lidocaine infusion</time_frame>
    <description>The psychological effect will be assessed using DASS21. Each of these domains is assessed with a separate 7-item scale. Responses to the items are summed to create scales with a total possible score of 21 points, then multiplied by two to calculate the final score. The final score can then be graded in each domain: Normal (0-4), Mild (5-6), Moderate (7-11), Severe (11-13), and Extremely Severe (14+) for depression; Normal (0-3), Mild (4-5), Moderate (6-7), Severe (8-9) and Extremely Severe (10+) for anxiety; and Normal (0-7), Mild (8-9), Moderate (10-12), Severe (13-16) and Extremely Severe (14+) for stress.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">29</enrollment>
  <condition>Peripheral Neuropathy</condition>
  <arm_group>
    <arm_group_label>Placebo group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Normal Saline 50 ml intravenous infusion in 1 hour once a week 4 times</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lidocaine group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Lidocaine 3mg/kg in Normal Saline to 50 ml intravenous infusion in 1 hour once a week 4 times</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lidocaine</intervention_name>
    <description>Lidocaine 3 mg/kg dilute in Normal Saline to 50 ml intravenous infusion in 1 hour</description>
    <arm_group_label>Lidocaine group</arm_group_label>
    <other_name>Intravenous lidocaine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Peripheral neuropathic pain from peripheral nerve injury within 6 months after injury&#xD;
&#xD;
          -  Well understand to Thai language in writing or listening&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Underlying Heart disease or Arrhythmia&#xD;
&#xD;
          -  Allergy to lidocaine, Gabapentin, Carbamazepine, tramadol&#xD;
&#xD;
          -  History of epilepsy&#xD;
&#xD;
          -  History of lidocaine used&#xD;
&#xD;
          -  Underlying Psychiatric disease&#xD;
&#xD;
          -  History of drug abuse&#xD;
&#xD;
          -  Pregnancy and nursing&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Suratsawadee Wangnamthip, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mahidol University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Faculty of medicine Siriraj Hospital Mahidol University</name>
      <address>
        <city>Bangkoknoi</city>
        <state>Bangkok</state>
        <zip>10700</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <link>
    <url>http://www.si.mahidol.ac.th/th/division/sirb/</url>
    <description>Siriraj Institutional Review Board</description>
  </link>
  <results_reference>
    <citation>Challapalli V, Tremont-Lukats IW, McNicol ED, Lau J, Carr DB. Systemic administration of local anesthetic agents to relieve neuropathic pain. Cochrane Database Syst Rev. 2005 Oct 19;2005(4):CD003345. doi: 10.1002/14651858.CD003345.pub2.</citation>
    <PMID>16235318</PMID>
  </results_reference>
  <results_reference>
    <citation>Attal N, Rouaud J, Brasseur L, Chauvin M, Bouhassira D. Systemic lidocaine in pain due to peripheral nerve injury and predictors of response. Neurology. 2004 Jan 27;62(2):218-25. doi: 10.1212/01.wnl.0000103237.62009.77.</citation>
    <PMID>14745057</PMID>
  </results_reference>
  <results_reference>
    <citation>Kingery WS. A critical review of controlled clinical trials for peripheral neuropathic pain and complex regional pain syndromes. Pain. 1997 Nov;73(2):123-139. doi: 10.1016/S0304-3959(97)00049-3.</citation>
    <PMID>9415498</PMID>
  </results_reference>
  <results_reference>
    <citation>Wallace MS, Dyck BJ, Rossi SS, Yaksh TL. Computer-controlled lidocaine infusion for the evaluation of neuropathic pain after peripheral nerve injury. Pain. 1996 Jul;66(1):69-77. doi: 10.1016/0304-3959(96)02980-6.</citation>
    <PMID>8857633</PMID>
  </results_reference>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>August 13, 2014</study_first_submitted>
  <study_first_submitted_qc>August 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2014</study_first_posted>
  <last_update_submitted>November 24, 2022</last_update_submitted>
  <last_update_submitted_qc>November 24, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 30, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Peripheral neuropathy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neuralgia</mesh_term>
    <mesh_term>Peripheral Nervous System Diseases</mesh_term>
  </condition_browse>
  <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/NCT02217267
org study id: SI140/2014
nct id: NCT02217267
lead sponsor: 
has dmc: Yes
The purpose of this study to evaluated Long term outcome after serial Lidocaine infusion when
      compared with placebo in peripheral neuropathic pain patients in acute stage (less than 6
      months) at 3 months after first time of infusion
Peripheral nerve injury may give rise to severe and long-lasting types of pains which are
      often resistant to treatment such as opioid, tricyclic antidepressant or anticonvulsant.
      Lidocaine infusion has been the one of intractable neuropathic pain treatment . My hypothesis
      the serial lidocaine infusion can adequate pain control and can prevent chronic pain (central
      sensitisation). Therefore, we designed this prospective, randomised, double-blind, controlled
      study to evaluate the efficacy of serial lidocaine infusion in peripheral neuropathic pain
      compared with placebo in long term outcome (at 3 month).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Pain intensity
time frame: at 3 months after serial lidocaine infusion
description: Pain intensity (Numerical Rating Scale; from 0-10) 0 means no pain, and 10 means worst pain imaginable.
measure: Quality of life using Utility score
time frame: at 3 month after serial lidocaine infusion
description: Quality of life will be assessed using EuroQol5D5L and reported as a utility score (0-1.0) "0" represents death, and "0.1" means full health
measure: Psychological effects on depression, anxiety and stress
time frame: at 3 month after serial lidocaine infusion
description: The psychological effect will be assessed using DASS21. Each of these domains is assessed with a separate 7-item scale. Responses to the items are summed to create scales with a total possible score of 21 points, then multiplied by two to calculate the final score. The final score can then be graded in each domain: Normal (0-4), Mild (5-6), Moderate (7-11), Severe (11-13), and Extremely Severe (14+) for depression; Normal (0-3), Mild (4-5), Moderate (6-7), Severe (8-9) and Extremely Severe (10+) for anxiety; and Normal (0-7), Mild (8-9), Moderate (10-12), Severe (13-16) and Extremely Severe (14+) for stress.
arm group label: Placebo group
arm group type: Placebo Comparator
description: Normal Saline 50 ml intravenous infusion in 1 hour once a week 4 times
arm group label: Lidocaine group
arm group type: Active Comparator
description: Lidocaine 3mg/kg in Normal Saline to 50 ml intravenous infusion in 1 hour once a week 4 times
intervention type: Drug
intervention name: Lidocaine
description: Lidocaine 3 mg/kg dilute in Normal Saline to 50 ml intravenous infusion in 1 hour
arm group label: Lidocaine group
other name: Intravenous lidocaine
intervention type: Drug
intervention name: Placebo
arm group label: Placebo group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Suratsawadee Wangnamthip, M.D.
role: Principal Investigator
affiliation: Mahidol University
facility: 
country: Thailand
url: http://www.si.mahidol.ac.th/th/division/sirb/
description: Siriraj Institutional Review Board
citation: Challapalli V, Tremont-Lukats IW, McNicol ED, Lau J, Carr DB. Systemic administration of local anesthetic agents to relieve neuropathic pain. Cochrane Database Syst Rev. 2005 Oct 19;2005(4):CD003345. doi: 10.1002/14651858.CD003345.pub2.
PMID: 16235318
citation: Attal N, Rouaud J, Brasseur L, Chauvin M, Bouhassira D. Systemic lidocaine in pain due to peripheral nerve injury and predictors of response. Neurology. 2004 Jan 27;62(2):218-25. doi: 10.1212/01.wnl.0000103237.62009.77.
PMID: 14745057
citation: Kingery WS. A critical review of controlled clinical trials for peripheral neuropathic pain and complex regional pain syndromes. Pain. 1997 Nov;73(2):123-139. doi: 10.1016/S0304-3959(97)00049-3.
PMID: 9415498
citation: Wallace MS, Dyck BJ, Rossi SS, Yaksh TL. Computer-controlled lidocaine infusion for the evaluation of neuropathic pain after peripheral nerve injury. Pain. 1996 Jul;66(1):69-77. doi: 10.1016/0304-3959(96)02980-6.
PMID: 8857633
responsible party type: Sponsor
mesh term: Neuralgia
mesh term: Peripheral Nervous System Diseases
mesh term: Lidocaine