The Role of Intravenous (IV) Lidocaine in the Management of Chronic Neuropathic Pain of Peripheral Nerve Origin
Information source: Lawson Health Research Institute
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Neuropathic Pain
Intervention: Lidocaine (Drug); Diphenhydramine (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Lawson Health Research Institute Official(s) and/or principal investigator(s): Dwight Moulin, Dr., Principal Investigator, Affiliation: University of Western Ontario, Canada
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.
Clinical Details
Official title: The Role of Intravenous (IV) Lidocaine in the Management of Chronic Neuropathic Pain of Peripheral Nerve Origin
Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)
Primary outcome: Changes from Baseline Pain scores on the Visual Analog Scale at 6 weeks
Secondary outcome: Hospital Anxiety and Depression ScaleModified Brief Pain Inventory Leeds Sleep Evaluation Questionnaire Patient Global Satisfaction with Treatment and Impression of Change Side Effects Quality of Life Health Outcome Instrument
Detailed description:
This study will examine the role of intravenous lidocaine in the relief of neuropathic pain
over four weeks following infusion compared to a salt water infusion. 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
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Chronic neuropathic pain of peripheral nerve origin as determined by the study
physician 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.
Locations and Contacts
St. Joseph's Health Care, London, Ontario N6A 4V2, Canada; Recruiting Cathy Rohfritsch, RN, Phone: 519-646-6019 Dwight Moulin, Dr., Principal Investigator
Additional Information
Starting date: September 2011
Last updated: August 20, 2012
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