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Lidocaine-Ketamine for Management of Chronic Pain

Primary Purpose

Chronic Pain Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lidocaine
Ketamine
Sponsored by
Hamilton Health Sciences Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain Syndrome focused on measuring lidocaine, ketamine, infusion

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18-90
  • Pain duration: > 3 months
  • Multifocal and/or non-dermatomal neuropathic pain per Pain Diagram
  • Failed medical management with at least 2 neuromodulation agents (e.g., gabapentinoids, antidepressants)
  • Neuropathic component (>15 points on S-LANSS)

Exclusion Criteria:

  • Non-English speakers
  • Refusal to sign informed consent
  • Body weight > 100 kg
  • Allergies to ketamine and/or lidocaine
  • Known contraindications to ketamine use which include poorly controlled systemic illnesses: arterial hypertension, hyperthyroidism, ischemic heart disease, heart failure, psychiatric comorbidity (e.g., history of psychosis, schizophrenia, dissociative state).
  • Known contraindication to lidocaine use which include current symptomatic or clinically significant brady- or tachyarrhythmia, systolic blood pressure <90 or >180 mmHg.
  • Scheduled interventions targeting neuropathic pain: epidural injections, peripheral nerve blocks, Bier block, radiofrequency of dorsal root ganglia and peripheral nerves, additional lidocaine or ketamine infusions
  • Newly added analgesic or neuromodulating medications, or recently performed interventions including lidocaine infusions (in the previous 3 months), or previous lidocaine/ketamine infusion in the previous 360 days. -Acute intoxication or active illegal substance abuse (excluding marijuana)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Lidocaine-Ketamine Infusion

    Arm 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.

    Outcomes

    Primary Outcome Measures

    Pain Unpleasantness Score
    Relative change on "Pain Unpleasantness Score". Moderate clinically important improvement is considered as 30% reduction.

    Secondary Outcome Measures

    Pain Interference
    Less Pain Interference measured by Short Form Brief Pain Inventory (SF-BPI)
    Neuropathic Pain
    Less Neuropathic pain measured by Self-Administered the Leads Assessment of Neuropathic Symptoms and Signs (S-LANSS)
    Functional Status
    Improved Functional Status measured by Patient Self-Efficacy Questionnaire (PSEQ)
    Emotional Status
    Improved Emotional Status measured by Beck Depression Inventory (BDI), Pain Catastrophizing Scale (PCS)
    Cognitive Status
    No change in Cognitive Status measured by Montreal Cognitive Assessment (MoCA)
    Quality of Life
    Improved Quality of Life measured by Global Improvement and Satisfaction Score
    Health Care Utilization
    Less Health Care Utilization measured by Self-report of number of physician, clinic visits for other reason, emergency department visit and hospitalizations
    Medication Use
    Less Medication Use determined by Type and Dose of medications

    Full Information

    First Posted
    August 10, 2017
    Last Updated
    August 10, 2017
    Sponsor
    Hamilton Health Sciences Corporation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03249025
    Brief Title
    Lidocaine-Ketamine for Management of Chronic Pain
    Official Title
    Ambulatory Infusion of Lidocaine and Ketamine for Management of Chronic Pain: An Observational Prospective Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 1, 2017 (Anticipated)
    Primary Completion Date
    September 1, 2018 (Anticipated)
    Study Completion Date
    September 1, 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hamilton Health Sciences Corporation

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Pain Syndrome
    Keywords
    lidocaine, ketamine, infusion

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    72 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Lidocaine-Ketamine Infusion
    Arm Type
    Experimental
    Arm 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(s)
    Lidocaine
    Intervention 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
    Intervention Type
    Drug
    Intervention Name(s)
    Ketamine
    Intervention 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
    Primary Outcome Measure Information:
    Title
    Pain Unpleasantness Score
    Description
    Relative change on "Pain Unpleasantness Score". Moderate clinically important improvement is considered as 30% reduction.
    Time Frame
    Baseline, 1, 2, 3, 4, 5, 6 and 12 Months
    Secondary Outcome Measure Information:
    Title
    Pain Interference
    Description
    Less Pain Interference measured by Short Form Brief Pain Inventory (SF-BPI)
    Time Frame
    Baseline, 1, 2, 3, 4, 5, 6 and 12 Months
    Title
    Neuropathic Pain
    Description
    Less Neuropathic pain measured by Self-Administered the Leads Assessment of Neuropathic Symptoms and Signs (S-LANSS)
    Time Frame
    Baseline, 1, 2, 3, 4, 5, 6 and 12 Months
    Title
    Functional Status
    Description
    Improved Functional Status measured by Patient Self-Efficacy Questionnaire (PSEQ)
    Time Frame
    Baseline, 1, 2, 3, 4, 5, 6 and 12 Months
    Title
    Emotional Status
    Description
    Improved Emotional Status measured by Beck Depression Inventory (BDI), Pain Catastrophizing Scale (PCS)
    Time Frame
    Baseline, 1, 2, 3, 4, 5, 6 and 12 Months
    Title
    Cognitive Status
    Description
    No change in Cognitive Status measured by Montreal Cognitive Assessment (MoCA)
    Time Frame
    Baseline, 1, 2, 3, 4, 5, 6 and 12 Months
    Title
    Quality of Life
    Description
    Improved Quality of Life measured by Global Improvement and Satisfaction Score
    Time Frame
    Baseline, 1, 2, 3, 4, 5, 6 and 12 Months
    Title
    Health Care Utilization
    Description
    Less Health Care Utilization measured by Self-report of number of physician, clinic visits for other reason, emergency department visit and hospitalizations
    Time Frame
    Baseline, 1, 2, 3, 4, 5, 6 and 12 Months
    Title
    Medication Use
    Description
    Less Medication Use determined by Type and Dose of medications
    Time Frame
    Baseline, 1, 2, 3, 4, 5, 6 and 12 Months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age 18-90 Pain duration: > 3 months Multifocal and/or non-dermatomal neuropathic pain per Pain Diagram Failed medical management with at least 2 neuromodulation agents (e.g., gabapentinoids, antidepressants) Neuropathic component (>15 points on S-LANSS) Exclusion Criteria: Non-English speakers Refusal to sign informed consent Body weight > 100 kg Allergies to ketamine and/or lidocaine Known contraindications to ketamine use which include poorly controlled systemic illnesses: arterial hypertension, hyperthyroidism, ischemic heart disease, heart failure, psychiatric comorbidity (e.g., history of psychosis, schizophrenia, dissociative state). Known contraindication to lidocaine use which include current symptomatic or clinically significant brady- or tachyarrhythmia, systolic blood pressure <90 or >180 mmHg. Scheduled interventions targeting neuropathic pain: epidural injections, peripheral nerve blocks, Bier block, radiofrequency of dorsal root ganglia and peripheral nerves, additional lidocaine or ketamine infusions Newly added analgesic or neuromodulating medications, or recently performed interventions including lidocaine infusions (in the previous 3 months), or previous lidocaine/ketamine infusion in the previous 360 days. -Acute intoxication or active illegal substance abuse (excluding marijuana)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Lisa Patterson, BA
    Phone
    905-521-5100
    Ext
    74279
    Email
    pattersl@hhsc.ca
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Michael Gofeld, MD, FRCPC
    Organizational Affiliation
    Michael G. DeGroote Pain Clinic, Hamilton Health Sciences
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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