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The Effect of Intravenous Lidocaine on Allodynia

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ClinicalTrials.gov Identifier: NCT00659633
Recruitment Status : Completed
First Posted : April 16, 2008
Results First Posted : June 8, 2017
Last Update Posted : July 21, 2017
Sponsor:
Collaborator:
American Society of Regional Anesthesia
Information provided by (Responsible Party):
Michael Froelich, University of Alabama at Birmingham

Study Description
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Brief Summary:
The purpose of this study is to study if lidocaine, given intravenously, reduces pain.

Condition or disease Intervention/treatment Phase
Pain Drug: lidocaine Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Intravenous Lidocaine on Allodynia (Carl Koller Grant)
Study Start Date : December 2008
Actual Primary Completion Date : June 2016
Actual Study Completion Date : August 2016

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Lidocaine
Intravenous lidocaine for neuropathic pain
 Drug: lidocaine
intravenous, effect site concentration: 2mcg/ml, 15-20 min infusion, once
Other Names:
  • Lidoderm
  • Xylocaine


Outcome Measures
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Primary Outcome Measures :
  1. Pain Perception [ Time Frame: Participants will be followed from baseline through 128 minutes ]

    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 (no pain) to 10 (worst imaginable pain) translates the patient's rating into a numeric scale.



Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00659633


Locations
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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249
Sponsors and Collaborators
University of Alabama at Birmingham
American Society of Regional Anesthesia
Investigators
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Principal Investigator: Michael Froelich, MD, MS University of Alabama at Birmingham
More Information
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Responsible Party: Michael Froelich, Associate Proffesor Anesthesiology M.D., University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00659633    
Other Study ID Numbers: F061204014
First Posted: April 16, 2008    Key Record Dates
Results First Posted: June 8, 2017
Last Update Posted: July 21, 2017
Last Verified: June 2017
Keywords provided by Michael Froelich, University of Alabama at Birmingham:
lidocaine
allodynia
chronic regional pain syndrome
pain
Additional relevant MeSH terms:
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Hyperalgesia
Somatosensory Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
 Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action