Action of Intra-auricular Topical Lidocaine on Tinnitus

• ClinicalTrials.gov Identifier: NCT05711641
• Recruitment Status: Active, not recruiting
• First Posted: February 3, 2023
• Last Update Posted: May 10, 2023
• Sponsor: University of Sao Paulo General Hospital
• Information provided by (Responsible Party): Ricardo Ferreira Bento, PhD, University of Sao Paulo General Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Tinnitus, Subjective	Drug: Lidocaine 10 MG/ML; Drug: Distilled water	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 33 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• 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.
• Masking: Double (Participant, Investigator)
• Masking Description: This is a double blind study. The substances are produced by the same handling pharmacy and delivered in identical vials, only with the information: substance 1 and substance 2.
• Primary Purpose: Diagnostic
• Official Title: Action of Intra-auricular Topical Lidocaine on Tinnitus
• Actual Study Start Date: September 2, 2022
• Estimated Primary Completion Date: June 2023
• Estimated Study Completion Date: June 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: Lidocaine 10%; 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; Application of 10% topical lidocaine in the external auditory canal of tinnitus patients.; Other Name: Active substance
Placebo Comparator: Placebo; 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; Application of distilled water in the external auditory canal of tinnitus patients.; Other Name: Placebo

Outcome Measures

Primary Outcome Measures :

1. Change in Visual Analogue Scale Pontuation [ Time Frame: Change in VAS pontuation from immediately before substance aplication at 5 minutes after. ]
   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.

Secondary Outcome Measures :

1. Change in Tinnitus loudness [ Time Frame: Change in tinnitus loudness from immediately before substance aplication at 5 minutes after. ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Brazil

Faculdade de Medicina da Universidade de São Paulo

São Paulo, Brazil, 01246903

Sponsors and Collaborators

University of Sao Paulo General Hospital

Investigators

• Principal Investigator: Ricardo F Bento; University of Sao Paulo

More Information

• Responsible Party: Ricardo Ferreira Bento, PhD, Professor of Otorhinolaringology Department of Faculdade de Medicina da Universidade de São Paulo, University of Sao Paulo General Hospital
• ClinicalTrials.gov Identifier: NCT05711641
• Other Study ID Numbers: 5562868
• First Posted: February 3, 2023
• Last Update Posted: May 10, 2023
• Last Verified: May 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by Ricardo Ferreira Bento, PhD, University of Sao Paulo General Hospital:

tinnitus; lidocaine; tinnitus treatment; tinnitus diagnosis; tinnitus suppression

Additional relevant MeSH terms:

Tinnitus; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Lidocaine; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents; Anti-Arrhythmia Agents; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action