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

This study is currently recruiting participants.
Verified August 2012 by Lawson Health Research Institute
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:

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
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
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Diphenhydramine
Promethazine
Lidocaine
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
 Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hypnotics and Sedatives
Central Nervous System Depressants
Anti-Allergic Agents
Anesthetics, Local
Anesthetics
Sensory System Agents
Antipruritics

ClinicalTrials.gov processed this record on May 23, 2013