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

Not Applicable

Completed

• Conditions: Neuropathic Pain
• Interventions: Drug: Diphenhydramine; Drug: Lidocaine

• Registration Number: NCT01669967
• Lead Sponsor: Lawson Health Research Institute

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.

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 Timeline

• Study Start: 2011-09
• Study First Submitted: 2012-06-22
• Study First Submitted QC: 2012-08-20
• Study First Posted: 2012-08-21
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-13
• Last Update Posted: 2019-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Diphenhydramine(Benadryl)	Diphenhydramine	-
Lidocaine	Lidocaine	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Hospital Anxiety and Depression Scale	obtained baseline, 24 and 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
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
Quality of Life Health Outcome Instrument	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

Trial Locations

Locations (1)

St. Joseph's Health Care; 🇨🇦 London, Ontario, Canada