<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/NCT03249025</url>
  </required_header>
  <id_info>
    <org_study_id>MGD-002-20170705</org_study_id>
    <nct_id>NCT03249025</nct_id>
  </id_info>
  <brief_title>Lidocaine-Ketamine for Management of Chronic Pain</brief_title>
  <official_title>Ambulatory Infusion of Lidocaine and Ketamine for Management of Chronic Pain: An Observational Prospective Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hamilton Health Sciences Corporation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hamilton Health Sciences Corporation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Chronic pain is defined as 'an unpleasant sensory and emotional experience associated with&#xD;
      actual or potential tissues damage, or described in terms of such damage&quot;. It is estimated&#xD;
      that 1 in 5 Canadians experience chronic pain &quot;Chronic pain is associated with the worst&#xD;
      quality of life compared with other chronic diseases such as chronic lung or heart disease&quot;.&#xD;
      Many of these problems are confined to a specific anatomic structure, and can be diagnosed&#xD;
      and treated by injections, physical therapy, surgery, etc. Nonetheless, other individuals&#xD;
      experience a more generalized pain. This condition has also resulted I depressed mood, bad&#xD;
      relations with other people, sleep disturbances and poor quality of life.&#xD;
&#xD;
      The condition is very difficult to manage, and multiple methods have been recommended.&#xD;
      Therapeutic intravenous infusion may be considered as one of these methods. Patients come for&#xD;
      infusions of non-opioid medications under medical supervision and in a scheduled fashion. Two&#xD;
      most commonly used mediation are lidocaine and ketamine.&#xD;
&#xD;
      Even though it is common to use multiple medications with complementary mechanisms of action&#xD;
      to treat pain a combined lidocaine-ketamine infusion has never been studied Therefore, the&#xD;
      purpose of this research study is to determine whether mixture of two medications (ketamine&#xD;
      and lidocaine) infused intravenously 1 time per month for 6 months results in reduction of&#xD;
      pain unpleasantness.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 1, 2017</start_date>
  <completion_date type="Anticipated">September 1, 2018</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2018</primary_completion_date>
  <phase>N/A</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain Unpleasantness Score</measure>
    <time_frame>Baseline, 1, 2, 3, 4, 5, 6 and 12 Months</time_frame>
    <description>Relative change on &quot;Pain Unpleasantness Score&quot;. Moderate clinically important improvement is considered as 30% reduction.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain Interference</measure>
    <time_frame>Baseline, 1, 2, 3, 4, 5, 6 and 12 Months</time_frame>
    <description>Less Pain Interference measured by Short Form Brief Pain Inventory (SF-BPI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neuropathic Pain</measure>
    <time_frame>Baseline, 1, 2, 3, 4, 5, 6 and 12 Months</time_frame>
    <description>Less Neuropathic pain measured by Self-Administered the Leads Assessment of Neuropathic Symptoms and Signs (S-LANSS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional Status</measure>
    <time_frame>Baseline, 1, 2, 3, 4, 5, 6 and 12 Months</time_frame>
    <description>Improved Functional Status measured by Patient Self-Efficacy Questionnaire (PSEQ)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Emotional Status</measure>
    <time_frame>Baseline, 1, 2, 3, 4, 5, 6 and 12 Months</time_frame>
    <description>Improved Emotional Status measured by Beck Depression Inventory (BDI), Pain Catastrophizing Scale (PCS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive Status</measure>
    <time_frame>Baseline, 1, 2, 3, 4, 5, 6 and 12 Months</time_frame>
    <description>No change in Cognitive Status measured by Montreal Cognitive Assessment (MoCA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life</measure>
    <time_frame>Baseline, 1, 2, 3, 4, 5, 6 and 12 Months</time_frame>
    <description>Improved Quality of Life measured by Global Improvement and Satisfaction Score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health Care Utilization</measure>
    <time_frame>Baseline, 1, 2, 3, 4, 5, 6 and 12 Months</time_frame>
    <description>Less Health Care Utilization measured by Self-report of number of physician, clinic visits for other reason, emergency department visit and hospitalizations</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medication Use</measure>
    <time_frame>Baseline, 1, 2, 3, 4, 5, 6 and 12 Months</time_frame>
    <description>Less Medication Use determined by Type and Dose of medications</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">72</enrollment>
  <condition>Chronic Pain Syndrome</condition>
  <arm_group>
    <arm_group_label>Lidocaine-Ketamine Infusion</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Lidocaine-Ketamine Infusions 1 time per month for 6 months. Pretreatment with Midazolam 1-3 mg IV Push or Subcutaneously and Clonidine 0.1 mg PO prior to infusion.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lidocaine</intervention_name>
    <description>Initial dose of 5.0 mg/kg (based on actual weight, up to maximum dose 600 mg) over 45-60 minutes, followed by increases of 0.5 mg/kg each infusion based on tolerability of side effects, to a maximum total dose of 600 mg. The initial and subsequent dose may be increased or decreased by 20% based on patient comorbidities, age and previous experience</description>
    <arm_group_label>Lidocaine-Ketamine Infusion</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ketamine</intervention_name>
    <description>initial dose of 0.25 mg/kg (based on actual weight) over 45-60 minutes (rounded to nearest 5 mg), increased by 10mg each infusion based on tolerability of side effects. The initial and subsequent dose may be increased or decreased by 20% based on patient comorbidities, age and previous experience</description>
    <arm_group_label>Lidocaine-Ketamine Infusion</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18-90&#xD;
&#xD;
          -  Pain duration: &gt; 3 months&#xD;
&#xD;
          -  Multifocal and/or non-dermatomal neuropathic pain per Pain Diagram&#xD;
&#xD;
          -  Failed medical management with at least 2 neuromodulation agents (e.g.,&#xD;
             gabapentinoids, antidepressants)&#xD;
&#xD;
          -  Neuropathic component (&gt;15 points on S-LANSS)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-English speakers&#xD;
&#xD;
          -  Refusal to sign informed consent&#xD;
&#xD;
          -  Body weight &gt; 100 kg&#xD;
&#xD;
          -  Allergies to ketamine and/or lidocaine&#xD;
&#xD;
          -  Known contraindications to ketamine use which include poorly controlled systemic&#xD;
             illnesses: arterial hypertension, hyperthyroidism, ischemic heart disease, heart&#xD;
             failure, psychiatric comorbidity (e.g., history of psychosis, schizophrenia,&#xD;
             dissociative state).&#xD;
&#xD;
          -  Known contraindication to lidocaine use which include current symptomatic or&#xD;
             clinically significant brady- or tachyarrhythmia, systolic blood pressure &lt;90 or &gt;180&#xD;
             mmHg.&#xD;
&#xD;
          -  Scheduled interventions targeting neuropathic pain: epidural injections, peripheral&#xD;
             nerve blocks, Bier block, radiofrequency of dorsal root ganglia and peripheral nerves,&#xD;
             additional lidocaine or ketamine infusions&#xD;
&#xD;
          -  Newly added analgesic or neuromodulating medications, or recently performed&#xD;
             interventions including lidocaine infusions (in the previous 3 months), or previous&#xD;
             lidocaine/ketamine infusion in the previous 360 days. -Acute intoxication or active&#xD;
             illegal substance abuse (excluding marijuana)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael Gofeld, MD, FRCPC</last_name>
    <role>Principal Investigator</role>
    <affiliation>Michael G. DeGroote Pain Clinic, Hamilton Health Sciences</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Lisa Patterson, BA</last_name>
    <phone>905-521-5100</phone>
    <phone_ext>74279</phone_ext>
    <email>pattersl@hhsc.ca</email>
  </overall_contact>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 10, 2017</study_first_submitted>
  <study_first_submitted_qc>August 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 15, 2017</study_first_posted>
  <last_update_submitted>August 10, 2017</last_update_submitted>
  <last_update_submitted_qc>August 10, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 15, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hamilton Health Sciences Corporation</investigator_affiliation>
    <investigator_full_name>Michael Gofeld</investigator_full_name>
    <investigator_title>Anesthesiologist</investigator_title>
  </responsible_party>
  <keyword>lidocaine</keyword>
  <keyword>ketamine</keyword>
  <keyword>infusion</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic Pain</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lidocaine</mesh_term>
    <mesh_term>Ketamine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03249025
org study id: MGD-002-20170705
nct id: NCT03249025
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Chronic pain is defined as 'an unpleasant sensory and emotional experience associated with
      actual or potential tissues damage, or described in terms of such damage". It is estimated
      that 1 in 5 Canadians experience chronic pain "Chronic pain is associated with the worst
      quality of life compared with other chronic diseases such as chronic lung or heart disease".
      Many of these problems are confined to a specific anatomic structure, and can be diagnosed
      and treated by injections, physical therapy, surgery, etc. Nonetheless, other individuals
      experience a more generalized pain. This condition has also resulted I depressed mood, bad
      relations with other people, sleep disturbances and poor quality of life.

      The condition is very difficult to manage, and multiple methods have been recommended.
      Therapeutic intravenous infusion may be considered as one of these methods. Patients come for
      infusions of non-opioid medications under medical supervision and in a scheduled fashion. Two
      most commonly used mediation are lidocaine and ketamine.

      Even though it is common to use multiple medications with complementary mechanisms of action
      to treat pain a combined lidocaine-ketamine infusion has never been studied Therefore, the
      purpose of this research study is to determine whether mixture of two medications (ketamine
      and lidocaine) infused intravenously 1 time per month for 6 months results in reduction of
      pain unpleasantness.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Pain Unpleasantness Score
time frame: Baseline, 1, 2, 3, 4, 5, 6 and 12 Months
description: Relative change on "Pain Unpleasantness Score". Moderate clinically important improvement is considered as 30% reduction.
measure: Pain Interference
time frame: Baseline, 1, 2, 3, 4, 5, 6 and 12 Months
description: Less Pain Interference measured by Short Form Brief Pain Inventory (SF-BPI)
measure: Neuropathic Pain
time frame: Baseline, 1, 2, 3, 4, 5, 6 and 12 Months
description: Less Neuropathic pain measured by Self-Administered the Leads Assessment of Neuropathic Symptoms and Signs (S-LANSS)
measure: Functional Status
time frame: Baseline, 1, 2, 3, 4, 5, 6 and 12 Months
description: Improved Functional Status measured by Patient Self-Efficacy Questionnaire (PSEQ)
measure: Emotional Status
time frame: Baseline, 1, 2, 3, 4, 5, 6 and 12 Months
description: Improved Emotional Status measured by Beck Depression Inventory (BDI), Pain Catastrophizing Scale (PCS)
measure: Cognitive Status
time frame: Baseline, 1, 2, 3, 4, 5, 6 and 12 Months
description: No change in Cognitive Status measured by Montreal Cognitive Assessment (MoCA)
measure: Quality of Life
time frame: Baseline, 1, 2, 3, 4, 5, 6 and 12 Months
description: Improved Quality of Life measured by Global Improvement and Satisfaction Score
measure: Health Care Utilization
time frame: Baseline, 1, 2, 3, 4, 5, 6 and 12 Months
description: Less Health Care Utilization measured by Self-report of number of physician, clinic visits for other reason, emergency department visit and hospitalizations
measure: Medication Use
time frame: Baseline, 1, 2, 3, 4, 5, 6 and 12 Months
description: Less Medication Use determined by Type and Dose of medications
arm group label: Lidocaine-Ketamine Infusion
arm group type: Experimental
description: Lidocaine-Ketamine Infusions 1 time per month for 6 months. Pretreatment with Midazolam 1-3 mg IV Push or Subcutaneously and Clonidine 0.1 mg PO prior to infusion.
intervention type: Drug
intervention name: Lidocaine
description: Initial dose of 5.0 mg/kg (based on actual weight, up to maximum dose 600 mg) over 45-60 minutes, followed by increases of 0.5 mg/kg each infusion based on tolerability of side effects, to a maximum total dose of 600 mg. The initial and subsequent dose may be increased or decreased by 20% based on patient comorbidities, age and previous experience
arm group label: Lidocaine-Ketamine Infusion
intervention type: Drug
intervention name: Ketamine
description: initial dose of 0.25 mg/kg (based on actual weight) over 45-60 minutes (rounded to nearest 5 mg), increased by 10mg each infusion based on tolerability of side effects. The initial and subsequent dose may be increased or decreased by 20% based on patient comorbidities, age and previous experience
arm group label: Lidocaine-Ketamine Infusion
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Michael Gofeld, MD, FRCPC
role: Principal Investigator
affiliation: Michael G. DeGroote Pain Clinic, Hamilton Health Sciences
last name: Lisa Patterson, BA
phone: 905-521-5100
phone ext: 74279
email: pattersl@hhsc.ca
responsible party type: Principal Investigator
investigator affiliation: Hamilton Health Sciences Corporation
investigator full name: Michael Gofeld
investigator title: Anesthesiologist
mesh term: Chronic Pain
mesh term: Lidocaine
mesh term: Ketamine
sharing ipd: No