The Effect of Intravenous Lidocaine on Allodynia - Tabular View

Tracking Information

First Received Date ^ICMJE

April 14, 2008

Last Updated Date

November 2, 2009

Start Date ^ICMJE

December 2008

Estimated Primary Completion Date

July 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00659633 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

The Effect of Intravenous Lidocaine on Allodynia

Official Title ^ICMJE

The Effect of Intravenous Lidocaine on Allodynia (Carl Koller Grant)

Brief Summary

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

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.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Open Label, Dose Comparison, Single Group Assignment, Efficacy Study

Condition ^ICMJE

Pain

Intervention ^ICMJE

Drug: lidocaine

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Completion Date

Estimated Primary Completion Date

July 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

19 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

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

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00659633

Responsible Party

Michael Froelich/Associate Professor, University of Alabama at Birmingham

Study ID Numbers ^ICMJE

F061204014

Study Sponsor ^ICMJE

University of Alabama at Birmingham

Collaborators ^ICMJE

American Society of Regional Anesthesia

Investigators ^ICMJE

Principal Investigator:

Michael Froelich, MD, MS

University of Alabama at Birmingham

Information Provided By

University of Alabama at Birmingham

Verification Date

November 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP