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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified August 2012 by Lawson Health Research Institute.
Recruitment status was Recruiting

Sponsor:

Information provided by (Responsible Party):

Dwight Moulin, Lawson Health Research Institute

ClinicalTrials.gov Identifier:

NCT01669967

First received: June 22, 2012

Last updated: August 20, 2012

Last verified: August 2012

History of Changes

Purpose

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	Intervention
Neuropathic Pain	Drug: Lidocaine Drug: Diphenhydramine


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator)
Official Title:	The Role of Intravenous (IV) Lidocaine in the Management of Chronic Neuropathic Pain of Peripheral Nerve Origin

Resource links provided by NLM:

Drug Information available for: Promethazine hydrochloride Diphenhydramine Promethazine Lidocaine hydrochloride Lidocaine Diphenhydramine hydrochloride Diphenhydramine citrate

U.S. FDA Resources

Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:

Changes from Baseline Pain scores on the Visual Analog Scale at 6 weeks [ Time Frame: every 24 hours for six weeks post-infusion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Hospital Anxiety and Depression Scale [ Time Frame: obtained baseline, 24 and 72 hours and then weeks 1,2,3, and 4 ] [ Designated as safety issue: No ]
Modified Brief Pain Inventory [ Time Frame: obtained baseline, 24, 72 hours and then weeks 1,2,3 and 4 ] [ Designated as safety issue: No ]
Leeds Sleep Evaluation Questionnaire [ Time Frame: obtained baseline, 24, 72 hours and then weeks 1,2,3 and 4 ] [ Designated as safety issue: No ]
Patient Global Satisfaction with Treatment and Impression of Change [ Time Frame: obtained baseline, 24, 72 hours and then weeks 1,2,3 and 4 ] [ Designated as safety issue: No ]
Side Effects [ Time Frame: obtained baseline, 24, 72 hours and then weeks 1,2,3 and 4 ] [ Designated as safety issue: No ]
Quality of Life Health Outcome Instrument [ Time Frame: obtained baseline, 24, 72 hours and then weeks 1,2,3 and 4 ] [ Designated as safety issue: No ]


Estimated Enrollment:	32
Study Start Date:	September 2011
Estimated Study Completion Date:	September 2013
Estimated Primary Completion Date:	September 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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


Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01669967

Locations


Canada, Ontario
St. Joseph's Health Care	Recruiting
London, Ontario, Canada, N6A 4V2
Contact: Cathy Rohfritsch, RN 519-646-6019
Principal Investigator: Dwight Moulin, Dr.

Sponsors and Collaborators

Lawson Health Research Institute

Investigators


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

More Information

No publications provided


Responsible Party:	Dwight Moulin, Dr. D. Moulin Professor, Departments of Clinical Neurological Sciences and Oncology, Lawson Health Research Institute
ClinicalTrials.gov Identifier:	NCT01669967 History of Changes
Other Study ID Numbers:	R11-132, 17806
Study First Received:	June 22, 2012
Last Updated:	August 20, 2012
Health Authority:	Canada: Health Canada Canada: Canadian Institutes of Health Research

Additional relevant MeSH terms:


Neuralgia Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Peripheral Nervous System Diseases Signs and Symptoms Diphenhydramine Lidocaine Promethazine Anesthetics Anesthetics, Local Anti-Allergic Agents Anti-Arrhythmia Agents Antiemetics	Antipruritics Autonomic Agents Cardiovascular Agents Central Nervous System Agents Central Nervous System Depressants Dermatologic Agents Gastrointestinal Agents Histamine Agents Histamine Antagonists Histamine H1 Antagonists Hypnotics and Sedatives Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on March 03, 2015

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