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
About this trial
This is an interventional treatment trial for Chronic Pain Syndrome focused on measuring lidocaine, ketamine, infusion
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)
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
NCT ID
NCT03249025
First Posted
August 10, 2017
Last Updated
August 10, 2017
Sponsor
Hamilton Health Sciences Corporation
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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Lidocaine-Ketamine for Management of Chronic Pain
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