Action of Intra-auricular Topical Lidocaine on Tinnitus

Study Overview
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Brief Summary
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The main objective of this clinical trial placebo controled is to evaluate the action of intraauricular topical lidocaine on tinnitus. The question to be answered is whether lidocaine is superior to placebo (distilled water) in reducing tinnitus intensity when applied topically within the external auditory canal. Tinnitus intensity will be measured using the visual analog scale and acuphenometry before and after lidocaine or placebo application.

Detailed Description
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Adult patients who have had continuous, uni or bilateral tinnitus, for at least 6 months are being evaluated. Exclusion criteria are: otological infection, tympanic membrane perforation, anatomical alteration of the external ear, pulsatile tinnitus, objective tinnitus, known allergy to lidocaine or other topical anesthetic and pregnancy All patients receive both lidocaine and placebo at an interval of 15 days and the order of application of the substances is randomized. Only one ear receives the medications and side is defined by the higher intensity of tinnitus, or through draw in the case of symmetrical tinnitus. The patient is instructed to lie in lateral decubitus, with the ear under study facing upwards and the substances are applied by filling the external auditory canal with lidocaine or distilled water for 5 min. Tinnitus intensity is measured (acuphenometry and VAS) before and after substance application and the variation is compared between lidocaine and placebo.

Official Title
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Action of Intra-auricular Topical Lidocaine on Tinnitus

Conditions
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Tinnitus, Subjective

Intervention / Treatment
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* Drug: Lidocaine 10 MG/ML
* Drug: Distilled water


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients who have had continuous, uni or bilateral tinnitus, for at least 6 months Exclusion Criteria: Otological infection Tympanic membrane perforation Anatomical alteration of the external ear Pulsatile tinnitus Objective tinnitus Known allergy to lidocaine or other topical anesthetic and pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: All patients will receive both lidocaine and placebo at an interval of 15 days and the order of application of the substances is randomized.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lidocaine 10%<br>The patient is instructed to lie down in lateral decubitus, with the ear in study facing upwards and 10% lidocaine is applied to the external auditory canal, using an eyedropper, until its complete filling (approximate average of 2ml). | Drug: Lidocaine 10 MG/ML<br>* Application of 10% topical lidocaine in the external auditory canal of tinnitus patients.<br>* Other names: Active substance;|
| Placebo Comparator: Placebo<br>The patient is instructed to lie down in lateral decubitus, with the ear in study facing upwards and distilled water is applied to the external auditory canal, using an eyedropper, until its complete filling (approximate average of 2ml). | Drug: Distilled water<br>* Application of distilled water in the external auditory canal of tinnitus patients.<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Visual Analogue Scale Pontuation | escla ranging from 0 to 10 points used to measure the intensity of tinnitus, where zero corresponds to the absence of tinnitus perception and 10 corresponds to the largest volume that the patient imagines that tinnitus may have. | Change in VAS pontuation from immediately before substance aplication at 5 minutes after. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Tinnitus loudness | Acuphenometry is a psychoacoustic test performed in an audiometry booth to measure tinnitus intensity. By comparing the intensity of tinnitus with the intensity sounds offered by the researcher, the tinnitus loudness is defined. | Change in tinnitus loudness from immediately before substance aplication at 5 minutes after. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tinnitus, lidocaine, tinnitus treatment, tinnitus diagnosis, tinnitus suppression