Lidocaine-Ketamine for Management of Chronic Pain

NCT ID: NCT03249025

Last Updated: 2017-08-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-01
• Study Completion Date: 2018-09-01

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Lidocaine

Intervention Type: 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

Ketamine

Intervention Type: 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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hamilton Health Sciences Corporation

OTHER

Sponsor Role: lead

Responsible Party

Michael Gofeld

Anesthesiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael Gofeld, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

Michael G. DeGroote Pain Clinic, Hamilton Health Sciences

Central Contacts

Lisa Patterson, BA

Role: CONTACT

pattersl@hhsc.ca

905-521-5100 ext. 74279

Other Identifiers

MGD-002-20170705

Identifier Type: -

Identifier Source: org_study_id