Lidocaine-Ketamine for Management of Chronic Pain

Ketamine

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.

Intervention / Treatment

  • Lidocaine (DRUG)
    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
  • Ketamine (DRUG)
    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

Condition or Disease

  • Chronic Pain Syndrome

Phase

  • Not Applicable

    • Study Design

    Study type: INTERVENTIONAL
    Status: Unknown status
    Study results: No Results Available
    Age: 18 Years to 90 Years
    Enrollment: 72 (ESTIMATED)
    Funded by: Other
    Allocation: N/A
    Primary Purpose: Treatment

    Masking

    Clinical Trial Dates

    Start date: Sep 01, 2017 ESTIMATED
    Primary Completion: Sep 01, 2018 ESTIMATED
    Completion Date: Sep 01, 2018 ESTIMATED
    Study First Posted: Aug 15, 2017 ACTUAL
    Results First Posted: Aug 31, 2020
    Last Updated: Aug 10, 2017

    Sponsors / Collaborators

    Lead Sponsor: Hamilton Health Sciences Corporation
    Responsible Party: N/A

    Participant Groups

    • 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.

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Maximum Age: 90
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    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)

    Primary Outcomes

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

    Secondary Outcomes

    • Less Pain Interference measured by Short Form Brief Pain Inventory (SF-BPI)

    • Less Neuropathic pain measured by Self-Administered the Leads Assessment of Neuropathic Symptoms and Signs (S-LANSS)

    • Improved Functional Status measured by Patient Self-Efficacy Questionnaire (PSEQ)

    • Improved Emotional Status measured by Beck Depression Inventory (BDI), Pain Catastrophizing Scale (PCS)

    • No change in Cognitive Status measured by Montreal Cognitive Assessment (MoCA)

    • Improved Quality of Life measured by Global Improvement and Satisfaction Score

    • Less Health Care Utilization measured by Self-report of number of physician, clinic visits for other reason, emergency department visit and hospitalizations

    • Less Medication Use determined by Type and Dose of medications

    More Details

    NCT Number: NCT03249025
    Other IDs: MGD-002-20170705
    Study URL: https://clinicaltrials.gov/study/NCT03249025
    Last updated: Sep 29, 2023