Clinical trial NCT01669967: The Role of Intravenous (IV) Lidocaine in the Management of Chronic Neuropathic Pain of Peripheral Nerve Origin
Official title: The Role of Intravenous (IV) Lidocaine in the Management of Chronic Neuropathic Pain of Peripheral Nerve Origin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neuropathic Pain
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2012-08-21
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Pain as a result of nerve injury (neuropathic pain) is a particularly severe form of chronic pain. Common examples of neuropathic pain are pain due to diabetes and shingles. There is good evidence that an intravenous infusion of lidocaine (local anesthetic) is useful for the management of neuropathic pain in the short term - up to six hours.

Detailed description: This study will examine the role of intravenous lidocaine in the relief of neuropathic pain over four weeks following infusion compared to an active placebo infusion of diphenhydramine(Benadryl) in normal saline. If we can show that intravenous lidocaine provides sustained benefit for up to one month, this will be a major advance in the management of individuals suffering from neuropathic pain.

Eligibility criteria: Inclusion Criteria:

* Chronic neuropathic pain due to diabetes mellitus or herpes zoster and a score of 4/10 or greater on the DN4 questionnaire.
* Moderate to severe pain as defined by screening average pain intensity of 5 or greater on a 0-10 numerical rating scale.
* Neuropathic pain duration of at least 6 months.

Exclusion Criteria:

* Presence of clinically significant cardiac disease.
* Poorly controlled seizure disorder.
* Significant psychiatric disorder.
* History of allergy to lidocaine or any other amide local anesthetic
* History of allergy to diphenhydramine.
* Prior treatment with a local anesthetic infusion.
* Neuropathic pain due to cancer or complex regional pain syndrome
* Language barrier or cognitive impairment that would preclude understanding of the study and filling out of questionnaires
* Lack of a driver to transport the patient to and from the pain clinic.

Primary outcomes:
measure: Changes from Baseline Pain scores on the Visual Analog Scale at 4 weeks
timeFrame: every 24 hours for four weeks post-infusion
Secondary outcomes:
measure: Hospital Anxiety and Depression Scale
timeFrame: obtained baseline, 24 and 72 hours and then weeks 1,2,3, and 4
measure: Modified Brief Pain Inventory
timeFrame: obtained baseline, 24, 72 hours and then weeks 1,2,3 and 4
measure: Leeds Sleep Evaluation Questionnaire
timeFrame: obtained baseline, 24, 72 hours and then weeks 1,2,3 and 4
measure: Patient Global Satisfaction with Treatment and Impression of Change
timeFrame: obtained baseline, 24, 72 hours and then weeks 1,2,3 and 4
measure: Side Effects
timeFrame: obtained baseline, 24, 72 hours and then weeks 1,2,3 and 4
measure: Quality of Life Health Outcome Instrument
timeFrame: obtained baseline, 24, 72 hours and then weeks 1,2,3 and 4
Other outcomes:
Locations:
city: London
country: Canada
facility: St. Joseph's Health Care
state: Ontario
Study officials:
affiliation: University of Western Ontario, Canada
name: Dwight Moulin, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Moulin DE, Morley-Forster PK, Pirani Z, Rohfritsch C, Stitt L. Intravenous lidocaine in the management of chronic peripheral neuropathic pain: a randomized-controlled trial. Can J Anaesth. 2019 Jul;66(7):820-827. doi: 10.1007/s12630-019-01395-8. Epub 2019 May 16.