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The Effect of Intravenous Lidocaine on Allodynia

Primary Purpose

Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
lidocaine
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring lidocaine, allodynia, chronic regional pain syndrome, pain

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lidocaine

Arm Description

Intravenous lidocaine for neuropathic pain

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
April 14, 2008
Last Updated
June 22, 2017
Sponsor
University of Alabama at Birmingham
Collaborators
American Society of Regional Anesthesia
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1. Study Identification

Unique Protocol Identification Number
NCT00659633
Brief Title
The Effect of Intravenous Lidocaine on Allodynia
Official Title
The Effect of Intravenous Lidocaine on Allodynia (Carl Koller Grant)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
American Society of Regional Anesthesia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
Keywords
lidocaine, allodynia, chronic regional pain syndrome, pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lidocaine
Arm Type
Experimental
Arm Description
Intravenous lidocaine for neuropathic pain
Intervention Type
Drug
Intervention Name(s)
lidocaine
Other Intervention Name(s)
Lidoderm, Xylocaine
Intervention Description
intravenous, effect site concentration: 2mcg/ml, 15-20 min infusion, once
Primary Outcome Measure Information:
Title
Pain Perception
Description
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.
Time Frame
Participants will be followed from baseline through 128 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Froelich, MD, MS
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249
Country
United States

12. IPD Sharing Statement

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The Effect of Intravenous Lidocaine on Allodynia

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