Action of Intra-auricular Topical Lidocaine on Tinnitus

University of Sao Paulo General Hospital

Status: Completed

Conditions: Tinnitus, Subjective

Treatments: Drug: Lidocaine 10 MG/ML; Drug: Distilled water

Study type: Interventional

Funder types: Other

Identifiers

NCT05711641

5562868

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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32 participants in 2 patient groups, including a placebo group

Lidocaine 10%

Experimental group

Description:

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).

Treatment:

Drug: Lidocaine 10 MG/ML

Placebo

Placebo Comparator group

Description:

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).

Treatment:

Drug: Distilled water