Ambulatory Infusions of Lidocaine and Ketamine for Management of Chronic Pain
NCT ID: NCT04123652
Last Updated: 2020-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
162 participants
INTERVENTIONAL
2017-11-05
2020-11-11
Brief Summary
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Detailed Description
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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 Pain Inventory (BPI-SF).
2. To evaluate the effects of lidocaine-ketamine infusions on the measures of Global Improvement and Satisfaction Score, Pain Self-Efficacy Questionnaire (PSEQ), Pain Catastrophic Scale (PCS), Beck Depression Inventory (BDI), and Patient self-reported perceived duration of effect (PSPDE).
3. To assess, analyze, and report adverse events
The study will be conducted per IMMPACT recommendations (17). Multi variable parameters will be captured: pain unpleasantness, physical function, emotional function, global improvement and satisfaction with treatment, adverse events and disposition. Additional instruments will be used in the triage process and follow-up (S-LANSS, PSEQ).
Number of subjects: all eligible consecutive patients accepted for lidocaine-ketamine infusions over period of 6 months.
Patients with multi focal and/or non-dermatomal pain with neuropathic component will be included.
Dosing and infusion orders are completed by one of the physician-investigators prior to patient arrival based on body weight, and modified if required after individual evaluation. Based on published literature and clinical impression, higher doses seem to be more effective and result in longer pain relief. Therefore, subsequent infusion doses will be increased to the maximally tolerated doses (i.e. minimal side effects).
Doses will be calculated using the following:
* Lidocaine - initial dose of 5.0 mg/kg +/- 1.0 mg/kg (based on actual weight, up to maximum dose 600 mg) over 45 minutes, followed by increases of 0.5 mg/kg each infusion based on tolerability of side effects, not to exceed 7 mg/kg or 600 mg.
* Ketamine - initial dose of 0.1 mg/kg (based on actual weight) over 45 minutes (rounded to nearest 5 mg, up to maximum 15 mg), increased by 0.1 mg/kg (rounded to nearest 5 mg) each infusion based on tolerability of side effects.
Standard clinic procedure will be followed for completing the infusions and managing side effects. The infusion will be initiated at 360 ml/hour for planned completion in 45 minutes, rate adjusted if side effects develop. Total doses of medication are recorded in the medical record.
Data collection and Management All study tools will be completed by patients online using, or in the clinic RedCap system. RedCap is a mature, secure web application for building and managing online surveys and databases (Vanderbilt University). The system is secured by SSL protocol and data is encrypted. Patients will be contacted via Email with a secure link to RedCap database, or if they would not be able to do it at home research, they can complete the questionnaires with research coordinator's assistant in secure computers at the clinic. Participant will receive reminders about upcoming visits and promoted to complete the follow-up forms. Allevio data protection is also SSL enabled and secured by SHA256, and they are issued by Rapid SSL and purchased through Ceerts4Less.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
Dosing and infusion orders are completed by one of the physician-investigators prior to patient arrival based on body weight, and modified if required after individual evaluation. Based on published literature and clinical impression, higher doses seem to be more effective and result in longer pain relief. Therefore, subsequent infusion doses will be increased to the maximally tolerated doses (i.e. minimal side effects).
Participants will be asked to complete the follow-up questionnaires every four weeks starting from their first infusion up to 8 times. On their last study visit, 4 weeks following the last infusion, participants will have an exit interview in addition to completing study measures.
TREATMENT
NONE
Study Groups
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Lidocaine and ketamine infusion
Lidocaine Hydrochloride 2% Intravenous Solution, DIN 02421992
An intravenous will be started. • Lidocaine - initial dose of 5.0 mg/kg +/- 1.0 mg/kg (based on actual weight, up to maximum dose 600 mg) over 45 minutes, followed by increases of 0.5 mg/kg each infusion based on tolerability of side effects, not to exceed 7 mg/kg or 600 mg.
• Ketamine - initial dose of 0.1 mg/kg (based on actual weight) over 45 minutes (rounded to nearest 5 mg, up to maximum 15 mg), increased by 0.1 mg/kg (rounded to nearest 5 mg) each infusion based on tolerability of side effects During the infusion patient will be monitored by another MD for BP, PR, PO2. Patients will not be allowed to drive for 24 hours.
Interventions
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Lidocaine Hydrochloride 2% Intravenous Solution, DIN 02421992
An intravenous will be started. • Lidocaine - initial dose of 5.0 mg/kg +/- 1.0 mg/kg (based on actual weight, up to maximum dose 600 mg) over 45 minutes, followed by increases of 0.5 mg/kg each infusion based on tolerability of side effects, not to exceed 7 mg/kg or 600 mg.
• Ketamine - initial dose of 0.1 mg/kg (based on actual weight) over 45 minutes (rounded to nearest 5 mg, up to maximum 15 mg), increased by 0.1 mg/kg (rounded to nearest 5 mg) each infusion based on tolerability of side effects During the infusion patient will be monitored by another MD for BP, PR, PO2. Patients will not be allowed to drive for 24 hours.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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 Criteria
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;
18 Years
90 Years
ALL
No
Sponsors
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Allevio Pain Management Clinic
OTHER
Responsible Party
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Principal Investigators
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Ramin Safakish, MD.FRCPC
Role: PRINCIPAL_INVESTIGATOR
Allevio Pain Management Clinic
Locations
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Allevio Pain Management Clinic
Toronto, Ontario, Canada
Countries
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References
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Other Identifiers
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16124-11:10:3610-082018
Identifier Type: -
Identifier Source: org_study_id