The Effect of Intravenous Lidocaine on Allodynia

This study is currently recruiting participants.

Verified February 2011 by University of Alabama at Birmingham

First Received on April 14, 2008. Last Updated on February 10, 2011 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:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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:	June 2011 (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: Alice Esame, BS Biology

205-934-4711

alicee@uab.edu

Locations

United States, Alabama
University of Alabama at Birmingham	Recruiting
Birmingham, Alabama, United States, 35249
Contact: Alice Esame, BS Biology 205-934-4711 alicee@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:	Michael Froelich/Associate Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:	NCT00659633 History of Changes
Other Study ID Numbers:	F061204014
Study First Received:	April 14, 2008
Last Updated:	February 10, 2011
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:

Hyperalgesia
Somatosensory Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System 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 February 12, 2012