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

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ClinicalTrials.gov Identifier: NCT04865185
Recruitment Status : Recruiting
First Posted : April 29, 2021
Last Update Posted : April 29, 2021
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Neuropathy;Peripheral Thermal Hypesthesia Diagnostic Test: Xylocaine spray 100mg/ml Diagnostic Test: Ethanol Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Diagnostic
Official Title: Effect of Topical Lidocaine on Warm and Cold Sensation in Healthy Individuals - a Randomized Crossover Trial
Actual Study Start Date : March 1, 2021
Estimated Primary Completion Date : February 28, 2022
Estimated Study Completion Date : February 28, 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Paradoxical heat sensation (PHS) [ Time Frame: 45 minutes ]
    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


Secondary Outcome Measures :
  1. Thermal Grill (TG) [ Time Frame: 75 minutes ]
    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

  2. Quality of the Thermal Grill (TG) [ Time Frame: 75 minutes ]
    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

  3. Pain intensity of the Thermal Grill (TG) [ Time Frame: 90 minutes ]
    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

  4. Intensity of unpleasantness of the Thermal Grill (TG) [ Time Frame: 95 minutes ]
    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

  5. Intensity of cold of the Thermal Grill (TG) [ Time Frame: 95 minutes ]

    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


  6. Intensity of warm of the Thermal Grill (TG) [ Time Frame: 95 minutes ]

    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


  7. Paradoxical heat sensation (PHS) [ Time Frame: 30 minutes before drug application ]
    Number of PHS responders at baseline without any treatment, 30 minutes before drug application

  8. Thermal Grill (TG) [ Time Frame: 20 minutes before drug application ]
    Number of TG responders at baseline without any treatment 20 minutes before drug application


Other Outcome Measures:
  1. Thermal thresholds [ Time Frame: 45 minutes ]

    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


  2. Paradoxical heat sensation (PHS) using a modified protocol [ Time Frame: 100 minutes ]
    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

  3. Mechanical thresholds [ Time Frame: 45 minutes ]

    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




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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04865185


Contacts
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Contact: Ellen L Schaldemose, MD +45 93501942 ells@clin.au.dk

Locations
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Denmark
Danish Pain Research Center, Aarhus University, Aarhus University Hospital Recruiting
Aarhus N, Denmark, 8200
Contact: Ellen L Schaldemose    93501942    ells@clin.au.dk   
Sponsors and Collaborators
University of Aarhus
Investigators
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Principal Investigator: Ellen L Schaldemose, MD Danish Pain Research Center, Aarhus University
  Study Documents (Full-Text)

Documents provided by University of Aarhus:
Statistical Analysis Plan  [PDF] March 1, 2021

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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT04865185    
Other Study ID Numbers: TLH21
First Posted: April 29, 2021    Key Record Dates
Last Update Posted: April 29, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Aarhus:
Paradoxical Heat Sensations
Thermal Grill Illusion
Lidocaine
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Hypesthesia
Neuromuscular Diseases
Nervous System Diseases
Somatosensory Disorders
Sensation Disorders
Neurologic Manifestations
Ethanol
Lidocaine
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Anesthetics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action