Lidocaine-Ketamine for Management of Chronic Pain

Sponsor

Hamilton Health Sciences Corporation (Other)

Overall Status

Unknown status

CT.gov ID

NCT03249025

Collaborator

(none)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Pain Syndrome	Drug: Lidocaine Drug: Ketamine	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

72 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Ambulatory Infusion of Lidocaine and Ketamine for Management of Chronic Pain: An Observational Prospective Study

Anticipated Study Start Date :

Sep 1, 2017

Anticipated Primary Completion Date :

Sep 1, 2018

Anticipated Study Completion Date :

Sep 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lidocaine-Ketamine Infusion 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.	Drug: Lidocaine 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 Drug: Ketamine 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

Intervention/Treatment

Experimental: Lidocaine-Ketamine Infusion

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.

Drug: Lidocaine

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

Drug: Ketamine

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

Outcome Measures

Primary Outcome Measures

Pain Unpleasantness Score [Baseline, 1, 2, 3, 4, 5, 6 and 12 Months]
Relative change on "Pain Unpleasantness Score". Moderate clinically important improvement is considered as 30% reduction.

Secondary Outcome Measures

Pain Interference [Baseline, 1, 2, 3, 4, 5, 6 and 12 Months]
Less Pain Interference measured by Short Form Brief Pain Inventory (SF-BPI)
Neuropathic Pain [Baseline, 1, 2, 3, 4, 5, 6 and 12 Months]
Less Neuropathic pain measured by Self-Administered the Leads Assessment of Neuropathic Symptoms and Signs (S-LANSS)
Functional Status [Baseline, 1, 2, 3, 4, 5, 6 and 12 Months]
Improved Functional Status measured by Patient Self-Efficacy Questionnaire (PSEQ)
Emotional Status [Baseline, 1, 2, 3, 4, 5, 6 and 12 Months]
Improved Emotional Status measured by Beck Depression Inventory (BDI), Pain Catastrophizing Scale (PCS)
Cognitive Status [Baseline, 1, 2, 3, 4, 5, 6 and 12 Months]
No change in Cognitive Status measured by Montreal Cognitive Assessment (MoCA)
Quality of Life [Baseline, 1, 2, 3, 4, 5, 6 and 12 Months]
Improved Quality of Life measured by Global Improvement and Satisfaction Score
Health Care Utilization [Baseline, 1, 2, 3, 4, 5, 6 and 12 Months]
Less Health Care Utilization measured by Self-report of number of physician, clinic visits for other reason, emergency department visit and hospitalizations
Medication Use [Baseline, 1, 2, 3, 4, 5, 6 and 12 Months]
Less Medication Use determined by Type and Dose of medications

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts 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)