NCT00659633

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable pain

Timeline
Completed

Started Dec 2008

Longer than P75 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 16, 2008

Completed
8 months until next milestone

Study Start

First participant enrolled

December 1, 2008

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
10 months until next milestone

Results Posted

Study results publicly available

June 8, 2017

Completed
Last Updated

July 21, 2017

Status Verified

June 1, 2017

Enrollment Period

7.5 years

First QC Date

April 14, 2008

Results QC Date

April 18, 2017

Last Update Submit

June 22, 2017

Conditions

Pain

Keywords

lidocaineallodyniachronic regional pain syndromepain

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Lidocaine

EXPERIMENTAL

Intravenous lidocaine for neuropathic pain

Drug: lidocaine

Interventions

lidocaineDRUG

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

Also known as: Lidoderm, Xylocaine
Lidocaine

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic Regional Pain Syndrome diagnostic criteria by the Work Safe BC. vi

You may not qualify if:

  • 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)
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35249, United States

Location

MeSH Terms

Conditions

PainHyperalgesiaComplex Regional Pain Syndromes

Interventions

LidocaineLidoderm

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSomatosensory DisordersSensation DisordersNervous System DiseasesAutonomic Nervous System DiseasesPeripheral Nervous System DiseasesNeuromuscular Diseases

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Results Point of Contact

Title
Dr. Michael Froelich
Organization
University of Alabama at Birmigham
mfroelich@uabmc.edu
205-975-3328

Study Officials

  • Michael Froelich, MD, MS

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Proffesor Anesthesiology M.D.

Study Record Dates

First Submitted

April 14, 2008

First Posted

April 16, 2008

Study Start

December 1, 2008

Primary Completion

June 1, 2016

Study Completion

August 1, 2016

Last Updated

July 21, 2017

Results First Posted

June 8, 2017

Record last verified: 2017-06

Locations

US(1)