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Local Anesthetic

Numbing Agents for Hearing Loss

Phase < 1
Waitlist Available
Research Sponsored by Our Lady of the Lake Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up immediately following the procedure to 6 months from procedure
Awards & highlights

Summary

This trial is testing whether or not a numbing drop (tetracaine) is more effective and less painful than a numbing agent applied directly to the eardrum (phenol) for people getting a steroid injection into the ear for Meniere's disease or idiopathic sudden sensorineural hearing loss.

Who is the study for?
Adults over 18 with Meniere's disease or sudden sensorineural hearing loss who need intratympanic steroid injections can join. It's not for those under 18, pregnant women, prisoners, people unable to consent in writing, or anyone with a current eardrum perforation.
What is being tested?
The trial is testing if Tetracaine drops are better than Phenol for numbing the ear during steroid injections. Patients will receive one of these anesthetics before their treatment to see which causes less pain and is more effective.
What are the potential side effects?
Possible side effects include burning sensation upon application of phenol and potential persistent eardrum perforation. Side effects from tetracaine may include local discomfort or allergic reactions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediately following the procedure to 6 months from procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately following the procedure to 6 months from procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Difference in Pain Score

Trial Design

2Treatment groups
Active Control
Group I: TetracaineActive Control1 Intervention
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.
Group II: PhenolActive Control1 Intervention
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).

Find a Location

Who is running the clinical trial?

Our Lady of the Lake HospitalLead Sponsor
12 Previous Clinical Trials
759 Total Patients Enrolled
Louisiana State University Health Sciences Center - New OrleansUNKNOWN
1 Previous Clinical Trials
440 Total Patients Enrolled

Media Library

Tetracaine 5% drops (Local Anesthetic) Clinical Trial Eligibility Overview. Trial Name: NCT04794842 — Phase < 1
Intratympanic Steroid Injections Research Study Groups: Tetracaine, Phenol
Intratympanic Steroid Injections Clinical Trial 2023: Tetracaine 5% drops Highlights & Side Effects. Trial Name: NCT04794842 — Phase < 1
Tetracaine 5% drops (Local Anesthetic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04794842 — Phase < 1
~20 spots leftby Sep 2025
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