Lidocaine-Ketamine for Management of Chronic Pain

Chronic Pain Syndrome Clinical Trial

Official title:

Ambulatory Infusion of Lidocaine and Ketamine for Management of Chronic Pain: An Observational Prospective Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03249025
• Other study ID #: MGD-002-20170705
• Status: Not yet recruiting
• Phase: N/A
• First received: August 10, 2017
• Last updated: August 10, 2017
• Start date: September 1, 2017
• Est. completion date: September 1, 2018

Study information

• Verified date: August 2017
• Source: Hamilton Health Sciences Corporation
• Contact: Lisa Patterson, BA
• Phone: 905-521-5100
• Email: pattersl[@]hhsc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 72
• Est. completion date: September 1, 2018
• Est. primary completion date: September 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Pain
• Chronic Pain Syndrome

Intervention

Drug:
• 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
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hamilton Health Sciences Corporation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pain Interference	Less Pain Interference measured by Short Form Brief Pain Inventory (SF-BPI)	Baseline, 1, 2, 3, 4, 5, 6 and 12 Months
Secondary	Neuropathic Pain	Less Neuropathic pain measured by Self-Administered the Leads Assessment of Neuropathic Symptoms and Signs (S-LANSS)	Baseline, 1, 2, 3, 4, 5, 6 and 12 Months
Secondary	Functional Status	Improved Functional Status measured by Patient Self-Efficacy Questionnaire (PSEQ)	Baseline, 1, 2, 3, 4, 5, 6 and 12 Months
Secondary	Emotional Status	Improved Emotional Status measured by Beck Depression Inventory (BDI), Pain Catastrophizing Scale (PCS)	Baseline, 1, 2, 3, 4, 5, 6 and 12 Months
Secondary	Cognitive Status	No change in Cognitive Status measured by Montreal Cognitive Assessment (MoCA)	Baseline, 1, 2, 3, 4, 5, 6 and 12 Months
Secondary	Quality of Life	Improved Quality of Life measured by Global Improvement and Satisfaction Score	Baseline, 1, 2, 3, 4, 5, 6 and 12 Months
Secondary	Health Care Utilization	Less Health Care Utilization measured by Self-report of number of physician, clinic visits for other reason, emergency department visit and hospitalizations	Baseline, 1, 2, 3, 4, 5, 6 and 12 Months
Secondary	Medication Use	Less Medication Use determined by Type and Dose of medications	Baseline, 1, 2, 3, 4, 5, 6 and 12 Months