Safety of Intravenous Lidocaine Infusions

Safety of Intravenous Lidocaine Infusions for Chronic Neuropathic Pain

The purpose of this study is to prospectively determine the side effects profile in adults with neuropathic pain receiving intravenous infusions of lidocaine 5 mg per kg of lean body weight, infused over 45 minutes.

Study Overview

• Status: Completed
• Conditions: Neuropathic Pain

Detailed Description

Eligibility Criteria:

Adults > 18 yrs with chronic central or peripheral neuropathic pain at the St Joseph's Health Care Pain Clinic between June and December 2009.

Outcome measures: All side effects spontaneously reported. Sedation, nausea, dizziness by Visual Analog Score Q 15 minutes; hemodynamic data q 5 minutes during and after infusion for 30 minutes.

Daily diary of side effects and Visual Analogue score of Pain for 7 days post-infusion.

• Study Type: Observational
• Enrollment (Actual): 70

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

• Sampling Method: Non-Probability Sample

Study Population

Adult outpatients attending St Joseph's Chronic Pain Clinic in one of two time periods who have been diagnosed with chronic neuropathic pain by clinical history and examination and are scheduled to receive a lidocaine infusion for pain management

Description

Inclusion Criteria:

• Adult outpatients > 18 years < 80 years diagnosed with chronic neuropathic pain

Exclusion Criteria:

• Unable to provide informed consent
• Unable to speak and understand English
• Liver, kidney, or cardiac failure
• Allergy to Lidocaine

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Lidocaine; Adults >18 yrs , attending St Joseph's Health Care Pain Clinic with a diagnosis of chronic neuropathic pain who are being treated with an lidocaine infusion of 5 mg/kg over 45 minutes Consecutive patients from two time periods: June 15 to August 21, 2009; October 15-Dec 22,2009

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute
• Collaborators: University of Western Ontario, Canada
• Investigators: Principal Investigator: Patricia K Morley-Forster, MD, FRCPC, Associate Professor,Dept of Anesthesia and Perioperative Medicine,University of Western Ontario, Lawson Health Research Institute; Principal Investigator: Patricia K Morley-Forster, MD, FRCPC, Associate Professor, University of Western Ontario, Lawson Health Research Institute

Publications and helpful links

General Publications

• Attal N, Gaude V, Brasseur L, Dupuy M, Guirimand F, Parker F, Bouhassira D. Intravenous lidocaine in central pain: a double-blind, placebo-controlled, psychophysical study. Neurology. 2000 Feb 8;54(3):564-74. doi: 10.1212/wnl.54.3.564.

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): January 1, 2010
• Study Completion (Actual): January 1, 2010

Study Registration Dates

• First Submitted: March 22, 2010
• First Submitted That Met QC Criteria: March 23, 2010
• First Posted (Estimate): March 24, 2010

Study Record Updates

• Last Update Posted (Estimate): March 24, 2010
• Last Update Submitted That Met QC Criteria: March 23, 2010
• Last Verified: March 1, 2010

More Information

Terms related to this study

• Keywords: Lidocaine,Intravenous Infusions,Neuropathic Pain,Side Effects
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia
• Other Study ID Numbers: R-08-341; 15240E (Other Identifier: REB)