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

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ClinicalTrials.gov Identifier: NCT01669967
Recruitment Status : Completed
First Posted : August 21, 2012
Last Update Posted : March 15, 2019
Sponsor:
Information provided by (Responsible Party):
Lawson Health Research Institute

Study Description
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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 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.
Study Design
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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

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Arms and Interventions
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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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Primary Outcome Measures :
  1. Changes from Baseline Pain scores on the Visual Analog Scale at 4 weeks [ Time Frame: every 24 hours for four 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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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01669967


Locations
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Canada, Ontario
St. Joseph's Health Care
London, Ontario, Canada, N6A 4V2
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
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Principal Investigator: Dwight Moulin, Dr. University of Western Ontario, Canada
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01669967    
Other Study ID Numbers: R11-132
17806 ( Other Identifier: University of Western Ontario )
First Posted: August 21, 2012    Key Record Dates
Last Update Posted: March 15, 2019
Last Verified: March 2019
Additional relevant MeSH terms:
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Neuralgia
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Diphenhydramine
Promethazine
Lidocaine
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
Sleep Aids, Pharmaceutical
Hypnotics and Sedatives
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Anti-Allergic Agents