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Comparing Topical Tetracaine Drops to Topical Focal Phenol for Local Anesthesia During Intratympanic Steroid Injection

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ClinicalTrials.gov Identifier: NCT04794842
Recruitment Status : Recruiting
First Posted : March 12, 2021
Last Update Posted : September 21, 2022
Sponsor:
Collaborator:
Louisiana State University Health Sciences Center - New Orleans
Information provided by (Responsible Party):
Leslie Son, Our Lady of the Lake Hospital

Brief Summary:
Intratympanic steroid injections are an accepted treatment for Meniere's disease and idiopathic sudden sensorineural hearing loss. This treatment is typically performed using local topical anesthesia. There is very limited research on the differences of medications and application procedures effect on patients' pain during the procedure.Topical Tetracaine solution and topical phenol have been shown to be effective as local anesthesia for the tympanic membrane when used for myringotomy. Currently there is no consensus on medication and technique however focally applied phenol is the more widely used technique. We believe this study can provide valuable information given the disadvantages of topical phenol including burning upon application as well as possible increase in persistent tympanic membrane perforation. The objectives are to determine the effectiveness of tetracaine drops for local anesthesia for intratympanic steroid injections compared to focal topical phenol application and to identify if tetracaine drops provides adequate anesthesia for intratympanic steroid injection with less pain on application than focal phenol.

Condition or disease Intervention/treatment Phase
Intratympanic Steroid Injection Idiopathic Sudden Sensorineural Hearing Loss Meniere Disease Drug: Tetracaine 5% drops Drug: Phenol 90% concentration Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Single-Blinded Randomized Cohort
Masking: Single (Participant)
Masking Description: Intervention choice blinded to the patient
Primary Purpose: Prevention
Official Title: Comparing Topical Tetracaine Drops to Topical Focal Phenol for Local Anesthesia During Intratympanic Steroid Injection
Actual Study Start Date : August 1, 2021
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023


Arm Intervention/treatment
Active Comparator: Tetracaine
Patients will be positioned in supine position at this time 0.5% tetracaine drops will be used to fill the ear canal. Tetracaine will then be allowed to stay in place for approximately 10 to 15 minutes with the patient's head positioned with affected ear up. After this, using an operative microscope the drops will be removed from the ear canal with suction.
Drug: Tetracaine 5% drops
same as information in the arm/group description

Active Comparator: Phenol
Patients will be positioned in supine position and tympanic membrane visualized with operative microscope. Phenol applicator will be used to topically apply 90% phenol to the injection site (posterior/Inferior aspect of tympanic membrane).
Drug: Phenol 90% concentration
same as information in the arm/group description




Primary Outcome Measures :
  1. Difference in Pain Score [ Time Frame: Immediately following the procedure to 6 months from procedure ]
    Evaluate any differences in pain scores assessed pre/post intervention and between the two topical anesthetics used prior to the intratympanic steroid injection


Secondary Outcome Measures :
  1. Statistical difference in tympanic membrane perforation presence or absence after the steroid injection procedure when using either tetracaine or phenol as the local anesthetic [ Time Frame: Immediately following the procedure to 6 months from procedure ]


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

Inclusion Criteria:

  • Adult subjects (18 years of age or greater)
  • Diagnosed with Idiopathic Sudden Sensorineural hearing loss or Meniere's disease
  • Care plan includes treatment via intratympanic steroid injection

Exclusion Criteria:

  • Having a current tympanic membrane perforation
  • Adults unable to sign written consent
  • Individuals less than 18 years of age
  • Pregnant women
  • Prisoners

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04794842


Contacts
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Contact: Leslie S Son, PhD 2257574165 Lson@lsuhsc.edu
Contact: Christine LeBeouf, DNP 2257655956 christine.leboeuf@fmolhs.org

Locations
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United States, Louisiana
Our Lady of the Lake Hospital Recruiting
Baton Rouge, Louisiana, United States, 70808
Contact: Leslie Son, Ph.D.    225-757-4165    lson@lsuhsc.edu   
Contact: Christine LeBoeuf, DNP    225-765-5956    christine.leboeuf@fmolhs.org   
Sponsors and Collaborators
Our Lady of the Lake Hospital
Louisiana State University Health Sciences Center - New Orleans
Publications:

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Responsible Party: Leslie Son, Academic Research Director, Our Lady of the Lake Hospital
ClinicalTrials.gov Identifier: NCT04794842    
Other Study ID Numbers: Tetracaine_vs_Phenol
First Posted: March 12, 2021    Key Record Dates
Last Update Posted: September 21, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Hearing Loss
Hearing Loss, Sensorineural
Meniere Disease
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Endolymphatic Hydrops
Labyrinth Diseases
Phenol
Tetracaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Sclerosing Solutions
Pharmaceutical Solutions