The Effect of Intravenous Lidocaine on Allodynia

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

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

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: lidocaine

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35249
      • University of Alabama at Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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: Xylocaine; Lidoderm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 (no pain) to 10 (worst imaginable pain) translates the patient's rating into a numeric scale.	Participants will be followed from baseline through 128 minutes

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: American Society of Regional Anesthesia

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (ACTUAL): June 1, 2016
• Study Completion (ACTUAL): August 1, 2016

Study Registration Dates

• First Submitted: April 14, 2008
• First Submitted That Met QC Criteria: April 14, 2008
• First Posted (ESTIMATE): April 16, 2008

Study Record Updates

• Last Update Posted (ACTUAL): July 21, 2017
• Last Update Submitted That Met QC Criteria: June 22, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: pain; lidocaine; allodynia; chronic regional pain syndrome
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Sensation Disorders; Somatosensory Disorders; Hyperalgesia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: F061204014