The Effect of Intravenous Lidocaine on Normal Sensation and Pain in Healthy Volunteers

This study has been completed.
Sponsor:
Collaborator:
American Society of Regional Anesthesia
Information provided by (Responsible Party):
University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00657358
First received: April 9, 2008
Last updated: November 24, 2013
Last verified: November 2013
  Purpose

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


Condition Intervention
Pain
Drug: Lidocaine

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of Intravenous Lidocaine on Normal Sensation and Pain in Healthy Volunteers (Carl Koller Grant) (The Effect of Intravenous Lidocaine on Allodynia)

Resource links provided by NLM:


Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • Ischemic Pain [ Time Frame: baseline, during 20 minute lidocaine infusion, and 30 minutes after discontinuation of lidocaine infusion ] [ Designated as safety issue: No ]
    The right arm was exsanguinated by elevating it above heart level for 30 seconds, after which the arm was occluded with a standard blood pressure cuff positioned proximal to the elbow inflated to twice the participant's mean arterial pressure. Participants then performed 20 handgrip exercises of 2-second duration at 4-second intervals at 50% of their maximum grip strength. Pain was rated on a scale from 0 - 10 with 0 being no pain to 10 being the worst pain imaginable.

  • Electrical Pain [ Time Frame: Baseline, during 20 minutes lidocaine infusion, and 30 minutes after completion of lidocaine infusion ] [ Designated as safety issue: No ]
    Peripheral nerve stimulation electrodes were attached to the base and the tip of the third digit and connected to a constant current stimulator (DS7A, Digitimer Ltd, Hertfordshire, England). Ascending electrical stimuli of 2000 mu duration, ranging from 0.5 to 35 mA (ampere) was administered one per second in 0.5 mA increments. Participants were instructed to indicate when they first felt the slightest sense of pain (electrical pain threshold, EPTh) and when they were unable to tolerate a further increase (electrical pain tolerance, EPTo). For each measure, the average of three trials was computed for use in subsequent analyses. Each of the three electrical pain stimuli were presented three times and balanced in order using a Graeco-Latin square design. The pain scale is between 0 and 10, with 0 being no pain and 10 being the worst pain imaginable

  • Heat Pain [ Time Frame: baseline, during 20 minute lidocaine infusion, and 30 minutes after completion of lidocaine infusion ] [ Designated as safety issue: No ]
    The thermal procedure involved a baseline assessment of heat pain threshold and tolerance. Contact heat stimuli were delivered using a computer-controlled Medoc Thermal Sensory Analyzer (TSA-II; Ramat Yishai, Israel), which is a peltier elementbased stimulator. Temperature levels were monitored by a thermistor and returned to a preset baseline of 32°C by active cooling at a rate of 10°C/s. The 3 × 3 cm contact probe was applied to the right forearm. The pain scale is between 0 and 10 with 1 being no pain and 10 being the worst pain imaginable

  • Cold Pain [ Time Frame: baseline, during 20 minute infusion, and 30 minutes after lidocaine infusion ] [ Designated as safety issue: No ]
    The participant's foot was immersed up to the ankle into a container filled with ice water of 3°C. Participants were instructed to maintain their foot in the container until the cold pain became intolerable (cold pain tolerance). The length of time was recorded in seconds. This procedure was repeated once with a gap of at least fifteen minutes in-between repeated tests. The range was 0 seconds to 120 seconds

  • Tactile Sensation [ Time Frame: baseline, during 20 minute infusion, and 30 minutes after completion of infusion ] [ Designated as safety issue: No ]
    Pin prick sensory thresholds (PPT) were obtained by touching the skin in-between the first and second metacarpal bone with a 23-gauge needles which moved freely out of a 10 mL plastic syringe barrel. The pin prick sensation was modified by adding small weights to the 23-gauge needles (from 0.2 to 5.2 gm). A syringe barrel of tuberculin (TB) needles that were cut to different lengths to add the desired weight to the 23-gauge needle. The PPT was determined using the weighted 23-gauge needle in ascending order, according to the method of limits. This assessment was to evaluate whether participants were able to feel the touch of the needle. The participant's arm was placed on a tray table. A linen sheet was suspended in-between two IV poles in such a fashion that the subject's view of his/her hand was blocked. Normal values are between 0.21mg and 5mg.


Enrollment: 22
Study Start Date: April 2008
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lidocaine
Lidocaine 2% (2mg/ml) was administered via a computer assisted infusion to achieve a target plasma concentration of 2 mcg/ml; infused within 20 minutes.
Drug: Lidocaine
Lidocaine 2% (2mg/ml) was administered via a computer assisted infusion to achieve a target plasma concentration of 2 mcg/ml; infused within 20 minutes.
Other Name: Local Anesthesia

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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy Adult Volunteers, age >19 years

Exclusion Criteria:

  • History of Substance Abuse
  • 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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Please refer to this study by its ClinicalTrials.gov identifier: NCT00657358

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
Sponsors and Collaborators
University of Alabama at Birmingham
American Society of Regional Anesthesia
Investigators
Principal Investigator: Michael Froelich, MD University of Alabama at Birmingham
  More Information

No publications provided

Responsible Party: University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00657358     History of Changes
Other Study ID Numbers: F061204013
Study First Received: April 9, 2008
Results First Received: May 24, 2012
Last Updated: November 24, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:
lidocaine
allodynia
chronic regional pain syndrome
pain

Additional relevant MeSH terms:
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 26, 2014