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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dwight Moulin, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01669967
First received: June 22, 2012
Last updated: March 19, 2016
Last verified: March 2016
  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:


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 ]

Enrollment: 34
Study Start Date: September 2011
Study Completion Date: December 2015
Primary Completion Date: December 2015 (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   (Adult, Senior)
Genders Eligible for Study:   Both
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
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
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

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: March 19, 2016
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
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

ClinicalTrials.gov processed this record on August 25, 2016