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

Neuropathic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01669967
• Other study ID #: R11-132
• Secondary ID: 17806
• Status: Completed
• Phase: N/A
• Start date: September 2011
• Est. completion date: December 2015

Study information

• Verified date: March 2019
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Pain

Intervention

Drug:
• Lidocaine
Lidocaine 5 mg/kg in 250 ml of normal saline infused over 45 minutes.
• Diphenhydramine
Diphenhydramine 50 mg in 250 ml of normal saline infused over 45 minutes.

Locations

Country	Name	City	State
Canada	St. Joseph's Health Care	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes from Baseline Pain scores on the Visual Analog Scale at 4 weeks		every 24 hours for four weeks post-infusion
Secondary	Hospital Anxiety and Depression Scale		obtained baseline, 24 and 72 hours and then weeks 1,2,3, and 4
Secondary	Modified Brief Pain Inventory		obtained baseline, 24, 72 hours and then weeks 1,2,3 and 4
Secondary	Leeds Sleep Evaluation Questionnaire		obtained baseline, 24, 72 hours and then weeks 1,2,3 and 4
Secondary	Patient Global Satisfaction with Treatment and Impression of Change		obtained baseline, 24, 72 hours and then weeks 1,2,3 and 4
Secondary	Side Effects		obtained baseline, 24, 72 hours and then weeks 1,2,3 and 4
Secondary	Quality of Life Health Outcome Instrument		obtained baseline, 24, 72 hours and then weeks 1,2,3 and 4