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

Neuropathy;Peripheral Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04865185
• Other study ID #: TLH21
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: February 28, 2022

Study information

• Verified date: March 2021
• Source: University of Aarhus
• Contact: Ellen L Schaldemose, MD
• Phone: +45 93501942
• Email: ells[@]clin.au.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: February 28, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypesthesia
• Neuropathy;Peripheral
• Peripheral Nervous System Diseases

Intervention

Diagnostic Test:
• Xylocaine spray 100mg/ml
Topical application
• Ethanol
Topical application

Locations

Country	Name	City	State
Denmark	Danish Pain Research Center, Aarhus University, Aarhus University Hospital	Aarhus N

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Paradoxical heat sensation (PHS)	Number of PHS responders at baseline without any treatment, 30 minutes before drug application	30 minutes before drug application
Secondary	Thermal Grill (TG)	Number of TG responders at baseline without any treatment 20 minutes before drug application	20 minutes before drug application