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

NCT ID: NCT01669967

Last Updated: 2019-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2015-12-31

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.

Conditions

Neuropathic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Diphenhydramine(Benadryl)

Group Type: PLACEBO_COMPARATOR

Diphenhydramine

Intervention Type: DRUG

Diphenhydramine 50 mg in 250 ml of normal saline infused over 45 minutes.

Lidocaine

Group Type: ACTIVE_COMPARATOR

Lidocaine

Intervention Type: DRUG

Lidocaine 5 mg/kg in 250 ml of normal saline infused over 45 minutes.

Interventions

Lidocaine

Lidocaine 5 mg/kg in 250 ml of normal saline infused over 45 minutes.

Intervention Type: DRUG

Diphenhydramine

Diphenhydramine 50 mg in 250 ml of normal saline infused over 45 minutes.

Intervention Type: DRUG

Other Intervention Names

Xylocaine; Benadryl

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dwight Moulin, Dr.

Role: PRINCIPAL_INVESTIGATOR

University of Western Ontario, Canada

Locations

St. Joseph's Health Care

London, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 31098961 (View on PubMed)

Other Identifiers

17806

Identifier Type: OTHER

Identifier Source: secondary_id

R11-132

Identifier Type: -

Identifier Source: org_study_id