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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00659633
Other study ID # F061204014
Secondary ID
Status Completed
Phase N/A
First received April 14, 2008
Last updated June 6, 2017
Start date December 2008
Est. completion date August 2016

Study information

Verified date June 2017
Source University of Alabama at Birmingham
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date August 2016
Est. primary completion date June 2016
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States University of Alabama at Birmingham Birmingham Alabama

Sponsors (2)

Lead Sponsor Collaborator
University of Alabama at Birmingham American Society of Regional Anesthesia

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain Perception Assessing heat pain perception (pain intensity) before, during, and after lidocaine infusion by means of patient self-report using a mechanical slide algometer.
The mechanical slide algometer [Price et al. (1994)] looks like a ruler that exposes a red bar with the end-points: no pain (left) and most pain imaginable (right). The use the slider to express their perceived pain. On the back of the ruler a numerical scale ranging from 0 top 10 translates the patient's rating into a numeric scale.
Participants will be followed from baseline through 128 minutes
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