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

NCT04865185 | Unknown

• 1 other identifier: TLH21
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuropathy;Peripheral; Thermal Hypesthesia

Keywords

Paradoxical Heat Sensations; Thermal Grill Illusion; Lidocaine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Thermal Grill (TG)

  75 minutes

• Quality of the Thermal Grill (TG)

  75 minutes

• Pain intensity of the Thermal Grill (TG)

  90 minutes

• Intensity of unpleasantness of the Thermal Grill (TG)

  95 minutes

• Intensity of cold of the Thermal Grill (TG)

  95 minutes

Other Outcomes (3)

• Thermal thresholds

  45 minutes

• Paradoxical heat sensation (PHS) using a modified protocol

  100 minutes

• Mechanical thresholds

  45 minutes

Study Arms (2)

Xylocaine spray 100mg/ml

ACTIVE COMPARATOR

Topical application

Diagnostic Test: Xylocaine spray 100mg/ml

Ethanol

PLACEBO COMPARATOR

Topical application

Diagnostic Test: Ethanol

Interventions

Xylocaine spray 100mg/ml DIAGNOSTIC_TEST

Topical application

Xylocaine spray 100mg/ml

Ethanol DIAGNOSTIC_TEST

Topical application

Ethanol

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Danish Pain Research Center, Aarhus University, Aarhus University Hospital

Aarhus N, 8200, Denmark

RECRUITING

MeSH Terms

Conditions

Neuritis; Hypesthesia

Condition Hierarchy (Ancestors)

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

Study Officials

• Ellen L Schaldemose, MD

  Danish Pain Research Center, Aarhus University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ellen L Schaldemose, MD

CONTACT

+45 93501942; ells@clin.au.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2021
• First Posted: April 29, 2021
• Study Start: March 1, 2021
• Primary Completion: February 28, 2022
• Study Completion: February 28, 2022
• Last Updated: April 29, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)