Lidocaine-Ketamine for Management of Chronic Pain

NCT03249025 | Unknown

• 1 other identifier: MGD-002-20170705
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Pain Syndrome

Keywords

lidocaine; ketamine; infusion

Outcome Measures

Primary Outcomes (1)

• Pain Unpleasantness Score

  Relative change on "Pain Unpleasantness Score". Moderate clinically important improvement is considered as 30% reduction.

  Baseline, 1, 2, 3, 4, 5, 6 and 12 Months

Secondary Outcomes (8)

• Pain Interference

  Baseline, 1, 2, 3, 4, 5, 6 and 12 Months

• Neuropathic Pain

  Baseline, 1, 2, 3, 4, 5, 6 and 12 Months

• Functional Status

  Baseline, 1, 2, 3, 4, 5, 6 and 12 Months

• Emotional Status

  Baseline, 1, 2, 3, 4, 5, 6 and 12 Months

• Cognitive Status

  Baseline, 1, 2, 3, 4, 5, 6 and 12 Months

Study Arms (1)

Lidocaine-Ketamine Infusion

EXPERIMENTAL

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; Drug: Ketamine

Interventions

Lidocaine DRUG

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

Lidocaine-Ketamine Infusion

Ketamine DRUG

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

Lidocaine-Ketamine Infusion

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead

MeSH Terms

Interventions

Lidocaine; Ketamine

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Michael Gofeld, MD, FRCPC

  Michael G. DeGroote Pain Clinic, Hamilton Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa Patterson, BA

CONTACT

905-521-5100; pattersl@hhsc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist

Study Record Dates

• First Submitted: August 10, 2017
• First Posted: August 15, 2017
• Study Start: September 1, 2017
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: August 15, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share