Status:
COMPLETED
Ambulatory Infusions of Lidocaine and Ketamine for Management of Chronic Pain
Lead Sponsor:
Allevio Pain Management Clinic
Conditions:
Chronic Neuropathic Pain and Fibromyalgia
Eligibility:
All Genders
18-90 years
Phase:
PHASE4
Brief Summary
As lidocaine and ketamine provide analgesia by acting on different molecular pathways, administering them together may produce synergistic effects, which can allow for using a lower dose of each medic...
Detailed Description
Study objectives 1. To evaluate effectiveness of lidocaine-ketamine infusions in reducing neuropathic pain, as assessed using the Revised Pain Quality Assessment Scale (PQAS-R) and Short Form Brief P...
Eligibility Criteria
Inclusion
- 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, cannabinoids);
- Neuropathic component (12 or more points on S-LANSS);
Exclusion
- Non-English speakers;
- Refusal to sign informed consent;
- Allergy to ketamine and/or lidocaine;
- Known relative contraindications to ketamine use which include poorly controlled systemic illnesses: hypertension, hyperthyroidism, ischemic heart disease, heart failure, psychiatric comorbidity (e.g., 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 within 30 days;
- Recently performed neuromodulating interventions within 90 days;
- Previous lidocaine-ketamine, lidocaine or ketamine infusion within 6 months;
- Acute intoxication or active illegal substance abuse;
Key Trial Info
Start Date :
November 5 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 11 2020
Estimated Enrollment :
162 Patients enrolled
Trial Details
Trial ID
NCT04123652
Start Date
November 5 2017
End Date
November 11 2020
Last Update
December 4 2020
Active Locations (1)
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1
Allevio Pain Management Clinic
Toronto, Ontario, Canada, M3B 3S6