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

NCT00657358 | Completed Results

• 1 other identifier: F061204013
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pain

Keywords

lidocaine; allodynia; chronic regional pain syndrome; pain

Outcome Measures

Primary Outcomes (5)

• Ischemic Pain

  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.

  baseline, during 20 minute lidocaine infusion, and 30 minutes after discontinuation of lidocaine infusion

• Electrical Pain

  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

  Baseline, during 20 minutes lidocaine infusion, and 30 minutes after completion of lidocaine infusion

• Heat Pain

  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

  baseline, during 20 minute lidocaine infusion, and 30 minutes after completion of lidocaine infusion

• Cold Pain

  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

  baseline, during 20 minute infusion, and 30 minutes after lidocaine infusion

• Tactile Sensation

  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 mg). 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.

  baseline, during 20 minute infusion, and 30 minutes after completion of infusion

Study Arms (1)

Lidocaine

EXPERIMENTAL

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

Interventions

Lidocaine DRUG

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.

Also known as: Local Anesthesia

Lidocaine

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy Adult Volunteers, age \>19 years

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• American Society of Regional Anesthesia: collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Conditions

Pain; Hyperalgesia; Complex Regional Pain Syndromes

Interventions

Lidocaine; Anesthesia, Local

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Somatosensory Disorders; Sensation Disorders; Nervous System Diseases; Autonomic Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Results Point of Contact

• Title: Dr. Michael Froelich
• Organization: UAB

froelich@uab.edu

205-975-0145

Study Officials

• Michael Froelich, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restriction Type: GT60

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: Michael A. Froelich, M.D.

Study Record Dates

• First Submitted: April 9, 2008
• First Posted: April 14, 2008
• Study Start: April 1, 2008
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: May 17, 2017
• Results First Posted: January 13, 2014

Record last verified: 2017-04

Locations

US (1)