Safety of Intravenous Lidocaine Infusions

This study has been completed.
Sponsor:
Collaborator:
University of Western Ontario, Canada
Information provided by:
Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01091935
First received: March 22, 2010
Last updated: March 23, 2010
Last verified: March 2010
  Purpose

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.


Condition
Neuropathic Pain

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Safety of Intravenous Lidocaine Infusions for Chronic Neuropathic Pain

Resource links provided by NLM:


Further study details as provided by Lawson Health Research Institute:

Enrollment: 70
Study Start Date: June 2009
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01091935

Locations
Canada, Ontario
St Joseph's Health Care
London, Ontario, Canada, N6A 4V2
Sponsors and Collaborators
Lawson Health Research Institute
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
  More Information

Publications:
Responsible Party: Patricia Morley-Forster, St Joseph's Health Care
ClinicalTrials.gov Identifier: NCT01091935     History of Changes
Other Study ID Numbers: R-08-341, 15240E
Study First Received: March 22, 2010
Last Updated: March 23, 2010
Health Authority: Canada: Ethics Review Committee

Keywords provided by Lawson Health Research Institute:
Lidocaine,Intravenous Infusions,Neuropathic Pain,Side Effects

Additional relevant MeSH terms:
Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on April 17, 2014