NCT01091935

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2009

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 22, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 24, 2010

Completed
Last Updated

March 24, 2010

Status Verified

March 1, 2010

Enrollment Period

7 months

First QC Date

March 22, 2010

Last Update Submit

March 23, 2010

Conditions

Neuropathic Pain

Keywords

Lidocaine,Intravenous Infusions,Neuropathic Pain,Side Effects

Study Arms (1)

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

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Joseph's Health Care

London, Ontario, N6A 4V2, Canada

Location

Related Publications (1)

  • 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.

    PMID: 10680784BACKGROUND

MeSH Terms

Conditions

Neuralgia

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 22, 2010

First Posted

March 24, 2010

Study Start

June 1, 2009

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

March 24, 2010

Record last verified: 2010-03

Locations

CA(1)