The Effect of Intravenous Lidocaine on Allodynia

This study is currently recruiting participants.

Verified by University of Alabama at Birmingham, November 2009

First Received: April 14, 2008 Last Updated: November 2, 2009 History of Changes

Sponsor:	University of Alabama at Birmingham
Collaborator:	American Society of Regional Anesthesia
Information provided by:	University of Alabama at Birmingham
ClinicalTrials.gov Identifier:	NCT00659633

Purpose

The purpose of this study is to study if lidocaine, given intravenously, reduces pain.

Condition	Intervention
Pain	Drug: lidocaine

Study Type:	Interventional
Study Design:	Treatment, Open Label, Dose Comparison, Single Group Assignment, Efficacy Study
Official Title:	The Effect of Intravenous Lidocaine on Allodynia (Carl Koller Grant)

Resource links provided by NLM:

Drug Information available for: Lidocaine

U.S. FDA Resources

Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:

Pain intensity [ Time Frame: before, during, and after intravenous lidocaine ] [ Designated as safety issue: No ]

Estimated Enrollment:	10
Study Start Date:	December 2008
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Intervention Details:

intravenous, effect site concentration: 2mcg/ml, 15-20 min infusion, once

Detailed Description:

Clinicians use lidocaine intravenously in a fashion that suggests that it might have analgesic effects. Therefore, we test the hypothesis that lidocaine reduces pain intensity in response to experimental pain.

Eligibility

Ages Eligible for Study:	19 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Chronic Regional Pain Syndrome diagnostic criteria by the Work Safe BC. vi

Exclusion Criteria:

History of Substance abuse
Other Medications: CRPS patients are expected to be treated for chronic pain, whether the current treatment regimen interferes with sensory motor testing will be determined on a case by case basis.
Coronary Artery Disease (CAD): unstable
Congestive Heart Failure (CHF): unstable
Heart Arrhythmia: symptomatic
Chronic Obstructive Pulmonary Disease (COPD)
Lidocaine Allergy
Diagnostic and Statistical Manual of Mental Disorders (Rev IV): Axis I: Common Axis I disorders include depression, anxiety disorders, bipolar disorder, ADHD, and schizophrenia. Axis II: borderline personality disorder, schizotypal personality disorder, antisocial personality disorder, and mild mental retardation.
Presence of Contraindications for MRI
Presence of electronically, magnetically, and mechanically activated implants
Electronically, magnetically, and mechanically activated implants
Ferromagnetic or electronically operated active devices like automatic cardioverter defibrillators
Cardiac pacemakers
Metallic splinters in the eye
Ferromagnetic haemostatic clips in the central nervous system (CNS)
Claustrophobia
Pregnancy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00659633

Contacts

Contact: Debbie Owen, BS	205-975-2088	debbieo@uab.edu
Contact: Jeff Worrell, RN, BSN, MPPM	205-975-2098	jworrell@uab.edu

Locations

United States, Alabama
University of Alabama at Birmingham	Recruiting
Birmingham, Alabama, United States, 35249
Contact: Debbie Owen, BS 205-975-2088 debbieo@uab.edu
Contact: Jeff Worrell, RN, BSN, MPPM 205-975-2098 jworrell@uab.edu
Principal Investigator: Michael Froelich, MD, MS
Sub-Investigator: Jason McKeown, MD
Sub-Investigator: Georg Deutsch, MD, PhD

Sponsors and Collaborators

University of Alabama at Birmingham

American Society of Regional Anesthesia

Investigators

Principal Investigator:

Michael Froelich, MD, MS

University of Alabama at Birmingham

More Information

No publications provided

Responsible Party:	University of Alabama at Birmingham ( Michael Froelich/Associate Professor )
Study ID Numbers:	F061204014
Study First Received:	April 14, 2008
Last Updated:	November 2, 2009
ClinicalTrials.gov Identifier:	NCT00659633 History of Changes
Health Authority:	United States: Food and Drug Administration; United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:

lidocaine
allodynia
chronic regional pain syndrome
pain

Additional relevant MeSH terms:

Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Lidocaine
Central Nervous System Depressants
Anesthetics

Cardiovascular Agents
Anti-Arrhythmia Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Pharmacologic Actions
Anesthetics, Local

ClinicalTrials.gov processed this record on November 09, 2009