Clinical trial NCT05711641: Action of Intra-auricular Topical Lidocaine on Tinnitus
Official title: Action of Intra-auricular Topical Lidocaine on Tinnitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tinnitus, Subjective
Keywords: tinnitus
lidocaine
tinnitus treatment
tinnitus diagnosis
tinnitus suppression
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2023-02-03
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: DIAGNOSTIC

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Visual Analogue Scale (VAS) Score
timeFrame: Immediately before and 5 minutes after receiving intervention on days 1 and 15
measure: Change in Tinnitus Loudness
timeFrame: Immediately before and 5 minutes after receiving intervention on days 1 and 15
measure: Change in Minimum Masking Level (MML)
timeFrame: Immediately before and 5 minutes after receiving intervention on days 1 and 15
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Faculdade de Medicina da Universidade de São Paulo
Study officials:
affiliation: University of Sao Paulo
name: Ricardo F Bento
role: PRINCIPAL_INVESTIGATOR
References: