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

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.

Study Overview

• Status: Completed
• Conditions: Neuropathic Pain
• Intervention / Treatment: Drug: Diphenhydramine; Drug: Lidocaine

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 Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Diphenhydramine(Benadryl)	Drug: Diphenhydramine; Diphenhydramine 50 mg in 250 ml of normal saline infused over 45 minutes.; Other Names: Benadryl
ACTIVE_COMPARATOR: Lidocaine	Drug: Lidocaine; Lidocaine 5 mg/kg in 250 ml of normal saline infused over 45 minutes.; Other Names: Xylocaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes from Baseline Pain scores on the Visual Analog Scale at 4 weeks	every 24 hours for four weeks post-infusion

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute
• Investigators: Principal Investigator: Dwight Moulin, Dr., University of Western Ontario, Canada

Publications and helpful links

General Publications

• Moulin DE, Morley-Forster PK, Pirani Z, Rohfritsch C, Stitt L. Intravenous lidocaine in the management of chronic peripheral neuropathic pain: a randomized-controlled trial. Can J Anaesth. 2019 Jul;66(7):820-827. doi: 10.1007/s12630-019-01395-8. Epub 2019 May 16.

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (ACTUAL): December 1, 2015
• Study Completion (ACTUAL): December 1, 2015

Study Registration Dates

• First Submitted: June 22, 2012
• First Submitted That Met QC Criteria: August 20, 2012
• First Posted (ESTIMATE): August 21, 2012

Study Record Updates

• Last Update Posted (ACTUAL): March 15, 2019
• Last Update Submitted That Met QC Criteria: March 13, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Antiemetics; Gastrointestinal Agents; Dermatologic Agents; Membrane Transport Modulators; Hypnotics and Sedatives; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Anti-Allergic Agents; Sleep Aids, Pharmaceutical; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Antipruritics; Lidocaine; Diphenhydramine; Promethazine
• Other Study ID Numbers: R11-132; 17806 (OTHER: University of Western Ontario)