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

Primary Purpose

Neuropathy;Peripheral, Thermal Hypesthesia

Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Xylocaine spray 100mg/ml
Ethanol
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Neuropathy;Peripheral focused on measuring Paradoxical Heat Sensations, Thermal Grill Illusion, Lidocaine

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Danish Pain Research Center, Aarhus University, Aarhus University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Xylocaine spray 100mg/ml

Ethanol

Arm Description

Topical application

Topical application

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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
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
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
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
Paradoxical heat sensation (PHS)
Number of PHS responders at baseline without any treatment, 30 minutes before drug application
Thermal Grill (TG)
Number of TG responders at baseline without any treatment 20 minutes before drug application

Full Information

First Posted
April 15, 2021
Last Updated
April 26, 2021
Sponsor
University of Aarhus
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1. Study Identification

Unique Protocol Identification Number
NCT04865185
Brief Title
Effect of Topical Lidocaine on Warm and Cold Sensation in Healthy Individuals
Official Title
Effect of Topical Lidocaine on Warm and Cold Sensation in Healthy Individuals - a Randomized Crossover Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
February 28, 2022 (Anticipated)
Study Completion Date
February 28, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathy;Peripheral, Thermal Hypesthesia
Keywords
Paradoxical Heat Sensations, Thermal Grill Illusion, Lidocaine

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Xylocaine spray 100mg/ml
Arm Type
Active Comparator
Arm Description
Topical application
Arm Title
Ethanol
Arm Type
Placebo Comparator
Arm Description
Topical application
Intervention Type
Diagnostic Test
Intervention Name(s)
Xylocaine spray 100mg/ml
Intervention Description
Topical application
Intervention Type
Diagnostic Test
Intervention Name(s)
Ethanol
Intervention Description
Topical application
Primary Outcome Measure Information:
Title
Paradoxical heat sensation (PHS)
Description
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
Time Frame
45 minutes
Secondary Outcome Measure Information:
Title
Thermal Grill (TG)
Description
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
Time Frame
75 minutes
Title
Quality of the Thermal Grill (TG)
Description
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
Time Frame
75 minutes
Title
Pain intensity of the Thermal Grill (TG)
Description
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
Time Frame
90 minutes
Title
Intensity of unpleasantness of the Thermal Grill (TG)
Description
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
Time Frame
95 minutes
Title
Intensity of cold of the Thermal Grill (TG)
Description
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
Time Frame
95 minutes
Title
Intensity of warm of the Thermal Grill (TG)
Description
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
Time Frame
95 minutes
Title
Paradoxical heat sensation (PHS)
Description
Number of PHS responders at baseline without any treatment, 30 minutes before drug application
Time Frame
30 minutes before drug application
Title
Thermal Grill (TG)
Description
Number of TG responders at baseline without any treatment 20 minutes before drug application
Time Frame
20 minutes before drug application
Other Pre-specified Outcome Measures:
Title
Thermal thresholds
Description
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
Time Frame
45 minutes
Title
Paradoxical heat sensation (PHS) using a modified protocol
Description
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
Time Frame
100 minutes
Title
Mechanical thresholds
Description
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
Time Frame
45 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ellen L Schaldemose, MD
Phone
+45 93501942
Email
ells@clin.au.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ellen L Schaldemose, MD
Organizational Affiliation
Danish Pain Research Center, Aarhus University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Danish Pain Research Center, Aarhus University, Aarhus University Hospital
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ellen L Schaldemose
Phone
93501942
Email
ells@clin.au.dk

12. IPD Sharing Statement

Plan to Share IPD
No

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

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