The Role of Intravenous (IV) Lidocaine in the Management of Chronic Neuropathic Pain of Peripheral Nerve Origin

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Neuropathic Pain	Drug: Lidocaine; Drug: Diphenhydramine	Not Applicable

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.

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	34 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	Triple (Participant, Care Provider, Investigator)
Primary Purpose:	Other
Official Title:	The Role of Intravenous (IV) Lidocaine in the Management of Chronic Neuropathic Pain of Peripheral Nerve Origin
Study Start Date :	September 2011
Actual Primary Completion Date :	December 2015
Actual Study Completion Date :	December 2015

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Placebo Comparator: Diphenhydramine(Benadryl)	Drug: Diphenhydramine; Diphenhydramine 50 mg in 250 ml of normal saline infused over 45 minutes.; Other Name: Benadryl
Active Comparator: Lidocaine	Drug: Lidocaine; Lidocaine 5 mg/kg in 250 ml of normal saline infused over 45 minutes.; Other Name: Xylocaine

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Changes from Baseline Pain scores on the Visual Analog Scale at 6 weeks [ Time Frame: every 24 hours for six weeks post-infusion ]

Secondary Outcome Measures :

1. Hospital Anxiety and Depression Scale [ Time Frame: obtained baseline, 24 and 72 hours and then weeks 1,2,3, and 4 ]
2. Modified Brief Pain Inventory [ Time Frame: obtained baseline, 24, 72 hours and then weeks 1,2,3 and 4 ]
3. Leeds Sleep Evaluation Questionnaire [ Time Frame: obtained baseline, 24, 72 hours and then weeks 1,2,3 and 4 ]
4. Patient Global Satisfaction with Treatment and Impression of Change [ Time Frame: obtained baseline, 24, 72 hours and then weeks 1,2,3 and 4 ]
5. Side Effects [ Time Frame: obtained baseline, 24, 72 hours and then weeks 1,2,3 and 4 ]
6. Quality of Life Health Outcome Instrument [ Time Frame: obtained baseline, 24, 72 hours and then weeks 1,2,3 and 4 ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Canada, Ontario
St. Joseph's Health Care
London, Ontario, Canada, N6A 4V2

Sponsors and Collaborators

Lawson Health Research Institute

Investigators

Principal Investigator:	Dwight Moulin, Dr.	University of Western Ontario, Canada

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Lawson Health Research Institute
ClinicalTrials.gov Identifier:	NCT01669967 History of Changes
Other Study ID Numbers:	R11-132; 17806 ( Other Identifier: University of Western Ontario )
First Posted:	August 21, 2012
Last Update Posted:	April 11, 2018
Last Verified:	March 2016

Additional relevant MeSH terms:

Neuralgia; Pain; Neurologic Manifestations; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Signs and Symptoms; Lidocaine; Diphenhydramine; Promethazine; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Sensory System Agents	Peripheral Nervous System Agents; Anti-Arrhythmia Agents; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Antiemetics; Autonomic Agents; Gastrointestinal Agents; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Neurotransmitter Agents; Hypnotics and Sedatives; Anti-Allergic Agents