Safety of Intravenous Lidocaine Infusions

NCT ID: NCT01091935

Last Updated: 2010-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-06-30

Study Completion Date

2010-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Neuropathic Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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:

1. June 15 to August 21, 2009
2. October 15-Dec 22,2009

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Western Ontario, Canada

OTHER

Sponsor Role collaborator

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

OTHER

Sponsor Role lead

Responsible Party

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St Joseph's Health Care

Principal Investigators

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Patricia K Morley-Forster, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

Associate Professor,Dept of Anesthesia and Perioperative Medicine,University of Western Ontario, Lawson Health Research Institute

Patricia K Morley-Forster, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

Associate Professor, University of Western Ontario, Lawson Health Research Institute

Locations

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St Joseph's Health Care

London, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type BACKGROUND
PMID: 10680784 (View on PubMed)

Other Identifiers

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15240E

Identifier Type: OTHER

Identifier Source: secondary_id

R-08-341

Identifier Type: -

Identifier Source: org_study_id

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