Chronic Pain Syndrome
Conditions
Keywords
lidocaine, ketamine, infusion
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.
Interventions
DRUGLidocaine
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
DRUGKetamine
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
Sponsors
Hamilton Health Sciences Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| Pain Interference | Baseline, 1, 2, 3, 4, 5, 6 and 12 Months | Less Pain Interference measured by Short Form Brief Pain Inventory (SF-BPI) |
| 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 |
| Cognitive Status | Baseline, 1, 2, 3, 4, 5, 6 and 12 Months | No change in Cognitive Status measured by Montreal Cognitive Assessment (MoCA) |
Contacts
Primary ContactLisa Patterson, BA
Outcome results
None listed