The Effect of Intravenous Lidocaine on Allodynia - Full Text View

The Effect of Intravenous Lidocaine on Allodynia

This study is not yet open for participant recruitment.
Verified by University of Alabama at Birmingham, April 2008

Sponsors and Collaborators:	University of Alabama at Birmingham 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

ChemIDplus related topics:

Lidocaine

U.S. FDA Resources

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)

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 2009 (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
	Birmingham, Alabama, United States
	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

Responsible Party:	University of Alabama at Birmingham ( Michael Froelich/Associate Professor )
Study ID Numbers:	F061204014
First Received:	April 14, 2008
Last Updated:	April 14, 2008
ClinicalTrials.gov Identifier:	NCT00659633
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

Study placed in the following topic categories:

Lidocaine

Pain

Additional relevant MeSH terms:

Sensory System Agents

Therapeutic Uses

Physiological Effects of Drugs

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 September 05, 2008