Lidocaine Clinical Trial
Official title:
A Mechanistic Evaluation of the Nociceptive Desensitization Induced by Repeated Administration of Topical Local Anaesthetic Mixture of Lidocaine and Prilocaine (EMLA) in a Model of Histaminergic and Non-histaminergic Itch.
Verified date | January 2021 |
Source | Aalborg University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
In this experiment, the investigators would like to study if the repeated application of local cuaneous anaesthetic EMLA cream will reduce itch induced by small needles from the plant mucuna pruriens (also known as cowhage) and histamine (an itch proving substance formed in the body).
Status | Completed |
Enrollment | 26 |
Est. completion date | January 1, 2021 |
Est. primary completion date | October 1, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: - Healthy men and women - 18-60 years - Speak and understand English Exclusion Criteria: - Pregnancy or lactation - Drug addiction defined as any use of cannabis, opioids or other drugs - Previous or current neurologic, musculoskeletal or mental illnesses - Lack of ability to cooperate - Current use of medications that may affect the trial - Skin diseases - Consumption of alcohol or painkillers 24 hours before the study days and between these - Acute or chronic pain - Participation in other trials within 1 week of study entry (4 weeks in the case of pharmaceutical trials) - Known history of anaphylactic shock, or local allergy (contact dermatitis) to lidocaine, prilocaine or other local anaesthetics of the amide type. |
Country | Name | City | State |
---|---|---|---|
Denmark | Aalborg University | Aalborg | Nordjylland |
Lead Sponsor | Collaborator |
---|---|
Aalborg University |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Superficial blood perfusion | is measured by a Speckle contrast imager (FLPI, Moor Instruments, England). | Change from baseline, up to three days after the first session | |
Primary | Warm Detection Thresholds and Heat Pain Thresholds | The tests for thermal sensation will all be performed using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device | Change from baseline, up to three days after the first session | |
Primary | Pain to Supra-threshold Heat Stimuli | The tests for thermal sensation will all be performed using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device | Change from baseline, up to three days after the first session | |
Primary | Alloknesis | Alloknesis is measured by using mildly pruritic, non-painful von Frey nylon filaments of a predetermined intensity (generally 5-30 miliNewton of force). | Change from baseline, up to three days after the first session | |
Primary | Mechanical Pain Thresholds and Sensitivity | This test is performed using a pin-prick set (Aalborg University, Aalborg). The set consists of 8 needles each having a diameter of 0.6 mm and different force applications: 0.8, 1.6, 3.2, 6.4, 12.8, 25.6, 50.1 and 60.0 g | Change from baseline, up to three days after the first session | |
Primary | Pain rating | The subject will rate the pain for 9 min by using a a visual analog scale (VAS) on a tablet. This scale goes from 0 to 100. 0 indicates 'no pain' and 100 indicates 'worst imaginable pain'. | only on day 3 (third session) | |
Secondary | Itch rating | The subject will rate the itch for 9 min by using a a visual analog scale (VAS) on a tablet. This scale goes from 0 to 100. 0 indicates 'no itch' and 100 indicated 'worst imaginable itch'. | only on day 3 (third session) |
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