Effect of Topical Lidocaine on Warm and Cold Sensation in Healthy Individuals

Effect of Topical Lidocaine on Warm and Cold Sensation in Healthy Individuals - a Randomized Crossover Trial

The purpose of the present study is to systematically test the occurrence of paradoxical and illusory responses to cold and warm stimuli in healthy volunteers with artificial sensory loss.

Study Overview

• Status: Recruiting
• Conditions: Neuropathy;Peripheral; Thermal Hypesthesia
• Intervention / Treatment: Diagnostic test: Xylocaine spray 100mg/ml; Diagnostic test: Ethanol

Detailed Description

Efficient thermal sensation is important for adequate behavioral response to cold or warm stimuli and early signs of neuropathy can be changes in the thermal sensation.

Alterations in thermal perception can results in paradoxical heat sensation (a warm perception when the skin is cooled) or a peculiar/burning sensation when the skin is stiumlated with simultaneous warm and cold (a "thermal grill").

Clarifying the occurrence of these paradoxical and illusory sensations, may help understanding early signs of peripheral neuropathy as well as thermal sensory perception.

The investigators plan to conduct a study on thermal sensory perception using a model of sensory loss in healthy volunteers and systematically test the occurrence of paradoxical heat sensations and responses to the thermal grill.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ellen L Schaldemose, MD; Phone Number: +45 93501942; Email: ells@clin.au.dk

Study Locations

• Denmark
  • Aarhus N, Denmark, 8200
    • Recruiting
    • Danish Pain Research Center, Aarhus University, Aarhus University Hospital
    • Contact: Ellen L Schaldemose; Phone Number: 93501942; Email: ells@clin.au.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy subjects
• Age between 18 and 40 years
• Participant is able and willing to give informed consent.

Exclusion Criteria:

• Unable to understand and speak Danish
• Non-cooperative
• Chronic pain or acute pain the past week lasting more than 4 hours or pain on the day of investigation
• Pain medication within the last week
• Medication within the last week that can affect assessment
• Psychiatric or neurological disease and diseases that may affect the assessment
• Sensory disturbances
• History or symptoms of significant diseases (e.g. psychiatric or neurological disease, diseases that may affect the assessment, sensory disturbances, cancer, diabetes mellitus, liver diseases, kidney diseases, cardiovascular diseases)
• Pregnancy or lactation
• Jetlag or sleep deprivation
• Alcohol or drug abuse
• Consumption of cannabis the last 4 weeks and consumption of alcohol in the last 48 hours
• Any abnormality of the skin or of vascular origin at application site
• History of hypersensitivity to lidocaine, other amide-type anesthetics, or other contents of the lidocaine or vehicle

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Xylocaine spray 100mg/ml; Topical application	Diagnostic test: Xylocaine spray 100mg/ml; Topical application
Placebo Comparator: Ethanol; Topical application	Diagnostic test: Ethanol; Topical application

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Paradoxical heat sensation (PHS)	Number of PHS responders on arm treated with lidocaine 45 minutes after drug application and Number of PHS responders on arm treated with ethanol 45 minutes after drug application	45 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Thermal Grill (TG)	Number of TG responders on arm treated with lidocaine 75 minutes after drug application and Number of TG responders on arm treated with ethanol 75 minutes after drug application	75 minutes
Quality of the Thermal Grill (TG)	The participants are asked whether the stimulus is burning, hot, warm, neutral, cold, or freezing cold after the TG-condition (warm and cold), only warm or only cold on arm treated with lidocaine 75 minutes after drug application The participants are asked whether the stimulus is burning, hot, warm, neutral, cold, or freezing cold after the TG-condition (warm and cold) or only warm or only cold on arm treated with ethanol 75 minutes after drug application	75 minutes
Pain intensity of the Thermal Grill (TG)	The participants are asked to rate the intensity of pain on a visual analog scale (VAS) 0-100 (0 no pain; 100 worst pain imaginable) after the TG-condition (warm and cold), only warm or only cold on arm treated with lidocaine 90 minutes after drug application The participants are asked to rate the intensity of pain on a VAS 0-100 (0 no pain; 100 worst pain imaginable) after the TG-condition (warm and cold), only warm or only cold on arm treated with ethanol 90 minutes after drug application	90 minutes
Intensity of unpleasantness of the Thermal Grill (TG)	The participants are asked to rate the intensity of unpleasantness on a VAS 0-100 (0 no unpleasantness; 100 worst unpleasantness imaginable) after the TG-condition (warm and cold), only warm or only cold on arm treated with lidocaine 95 minutes after drug application The participants are asked to rate the intensity of unpleasantness on a VAS 0-100 (0 no unpleasantness; 100 worst unpleasantness imaginable) after the TG-condition (warm and cold), only warm or only cold on arm treated with ethanol 95 minutes after drug application	95 minutes
Intensity of cold of the Thermal Grill (TG)	The participants are asked to rate the intensity of unpleasantness on a VAS 0-100 (0 no cold; 100 extremely cold ) after the TG-condition (warm and cold), only warm or only cold on arm treated with lidocaine 95 minutes after drug application The participants are asked to rate the intensity of unpleasantness on a VAS 0-100 (0 no cold; 100 extremely cold ) after the TG-condition (warm and cold), only warm or only cold on arm treated with ethanol 95 minutes after drug application	95 minutes
Intensity of warm of the Thermal Grill (TG)	The participants are asked to rate the intensity of unpleasantness on a VAS 0-100 (0 no warm; 100 extremely warm ) after the TG-condition (warm and cold), only warm or only cold on arm treated with lidocaine 95 minutes after drug application The participants are asked to rate the intensity of unpleasantness on a VAS 0-100 (0 no warm; 100 extremely warm ) after the TG-condition (warm and cold), only warm or only cold on arm treated with ethanol 95 minutes after drug application	95 minutes
Paradoxical heat sensation (PHS)	Number of PHS responders at baseline without any treatment, 30 minutes before drug application	30 minutes before drug application
Thermal Grill (TG)	Number of TG responders at baseline without any treatment 20 minutes before drug application	20 minutes before drug application

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Thermal thresholds	Detection- and pain thresholds for cold, warm (degrees) stimuli at baseline without any treatment Detection- and pain thresholds for cold, warm (degrees) stimuli on arm treated with lidocaine 45 minutes after drug application Detection- and pain thresholds for cold, warm (degrees) stimuli on arm treated with ethanol 45 minutes after drug application	45 minutes
Paradoxical heat sensation (PHS) using a modified protocol	Number of PHS responders if the skin is heated or cooled prior the test at baseline without any treatment Number of PHS responders if the skin is heated or cooled prior the test on arm treated with lidocaine 100 minutes after drug application Number of PHS responders if the skin is heated or cooled prior the test on arm treated with ethanol 100 minutes after drug application	100 minutes
Mechanical thresholds	Detection- and pain thresholds for mechanical (mNewton) stimuli at baseline without any treatment Detection- and pain thresholds for mechanical (mNewton) stimuli on arm treated with lidocaine 45 minutes after drug application Detection- and pain thresholds for mechanical (mNewton) stimuli on arm treated with ethanol 45 minutes after drug application	45 minutes

Collaborators and Investigators

• Sponsor: University of Aarhus
• Investigators: Principal Investigator: Ellen L Schaldemose, MD, Danish Pain Research Center, Aarhus University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Anticipated): February 28, 2022
• Study Completion (Anticipated): February 28, 2022

Study Registration Dates

• First Submitted: April 15, 2021
• First Submitted That Met QC Criteria: April 26, 2021
• First Posted (Actual): April 29, 2021

Study Record Updates

• Last Update Posted (Actual): April 29, 2021
• Last Update Submitted That Met QC Criteria: April 26, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Lidocaine; Paradoxical Heat Sensations; Thermal Grill Illusion
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Diseases; Sensation Disorders; Somatosensory Disorders; Peripheral Nervous System Diseases; Hypesthesia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Anti-Infective Agents, Local; Anti-Infective 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; Ethanol; Lidocaine
• Other Study ID Numbers: TLH21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No