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

Primary Purpose

Intratympanic Steroid Injection, Idiopathic Sudden Sensorineural Hearing Loss, Meniere Disease

Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Tetracaine 5% drops
Phenol 90% concentration
Sponsored by
Our Lady of the Lake Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Intratympanic Steroid Injection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Our Lady of the Lake HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Tetracaine

Phenol

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

Difference in Pain Score
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

Statistical difference in tympanic membrane perforation presence or absence after the steroid injection procedure when using either tetracaine or phenol as the local anesthetic

Full Information

First Posted
March 9, 2021
Last Updated
September 20, 2022
Sponsor
Our Lady of the Lake Hospital
Collaborators
Louisiana State University Health Sciences Center - New Orleans
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1. Study Identification

Unique Protocol Identification Number
NCT04794842
Brief Title
Comparing Topical Tetracaine Drops to Topical Focal Phenol for Local Anesthesia During Intratympanic Steroid Injection
Official Title
Comparing Topical Tetracaine Drops to Topical Focal Phenol for Local Anesthesia During Intratympanic Steroid Injection
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Our Lady of the Lake Hospital
Collaborators
Louisiana State University Health Sciences Center - New Orleans

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intratympanic Steroid Injection, Idiopathic Sudden Sensorineural Hearing Loss, Meniere Disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Single-Blinded Randomized Cohort
Masking
Participant
Masking Description
Intervention choice blinded to the patient
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tetracaine
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Phenol
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Tetracaine 5% drops
Intervention Description
same as information in the arm/group description
Intervention Type
Drug
Intervention Name(s)
Phenol 90% concentration
Intervention Description
same as information in the arm/group description
Primary Outcome Measure Information:
Title
Difference in Pain Score
Description
Evaluate any differences in pain scores assessed pre/post intervention and between the two topical anesthetics used prior to the intratympanic steroid injection
Time Frame
Immediately following the procedure to 6 months from procedure
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Leslie S Son, PhD
Phone
2257574165
Email
Lson@lsuhsc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Christine LeBeouf, DNP
Phone
2257655956
Email
christine.leboeuf@fmolhs.org
Facility Information:
Facility Name
Our Lady of the Lake Hospital
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leslie Son, Ph.D.
Phone
225-757-4165
Email
lson@lsuhsc.edu
First Name & Middle Initial & Last Name & Degree
Christine LeBoeuf, DNP
Phone
225-765-5956
Email
christine.leboeuf@fmolhs.org

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23378346
Citation
Filipo R, Attanasio G, Russo FY, Viccaro M, Mancini P, Covelli E. Intratympanic steroid therapy in moderate sudden hearing loss: a randomized, triple-blind, placebo-controlled trial. Laryngoscope. 2013 Mar;123(3):774-8. doi: 10.1002/lary.23678. Epub 2013 Feb 1.
Results Reference
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PubMed Identifier
21646929
Citation
Wu HP, Chou YF, Yu SH, Wang CP, Hsu CJ, Chen PR. Intratympanic steroid injections as a salvage treatment for sudden sensorineural hearing loss: a randomized, double-blind, placebo-controlled study. Otol Neurotol. 2011 Jul;32(5):774-9. doi: 10.1097/MAO.0b013e31821fbdd1.
Results Reference
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PubMed Identifier
27650470
Citation
Leng Y, Liu B, Zhou R, Liu J, Liu D, Zhang SL, Kong WJ. Repeated courses of intratympanic dexamethasone injection are effective for intractable Meniere's disease. Acta Otolaryngol. 2017 Feb;137(2):154-160. doi: 10.1080/00016489.2016.1224920. Epub 2016 Sep 21.
Results Reference
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PubMed Identifier
25188506
Citation
McRackan TR, Best J, Pearce EC, Bennett ML, Dietrich M, Wanna GB, Haynes DS, Labadie RF. Intratympanic dexamethasone as a symptomatic treatment for Meniere's disease. Otol Neurotol. 2014 Oct;35(9):1638-40. doi: 10.1097/MAO.0000000000000500.
Results Reference
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PubMed Identifier
22203120
Citation
Belhassen S, Saliba I. Pain assessment of the intratympanic injections: a prospective comparative study. Eur Arch Otorhinolaryngol. 2012 Dec;269(12):2467-73. doi: 10.1007/s00405-011-1897-z. Epub 2011 Dec 28.
Results Reference
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PubMed Identifier
5794873
Citation
Silverstein H, Call DL. Tetracaine base. An effective surface anesthetic for the tympanic membrane. Arch Otolaryngol. 1969 Aug;90(2):150-1. doi: 10.1001/archotol.1969.00770030152010. No abstract available.
Results Reference
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PubMed Identifier
21681571
Citation
Kumar R, Banerjee A. Myringotomy and ventilation tube insertion with minims tetracaine drops. Eur Arch Otorhinolaryngol. 2011 Oct;268(10):1533-4. doi: 10.1007/s00405-011-1654-3. Epub 2011 Jun 17.
Results Reference
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PubMed Identifier
11568619
Citation
Hoffman RA, Li CL. Tetracaine topical anesthesia for myringotomy. Laryngoscope. 2001 Sep;111(9):1636-8. doi: 10.1097/00005537-200109000-00027.
Results Reference
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PubMed Identifier
16375777
Citation
Robertson A, Whitwell R, Osborne J. Is phenol a safe local anaesthetic for grommet insertion? J Laryngol Otol. 2006 Jan;120(1):20-3. doi: 10.1017/S0022215105005840.
Results Reference
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PubMed Identifier
6823169
Citation
Weisskopf A. Phenol anesthesia for myringotomy. Laryngoscope. 1983 Jan;93(1):114. doi: 10.1288/00005537-198301000-00022. No abstract available.
Results Reference
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PubMed Identifier
22588748
Citation
Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S240-52. doi: 10.1002/acr.20543. No abstract available.
Results Reference
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Comparing Topical Tetracaine Drops to Topical Focal Phenol for Local Anesthesia During Intratympanic Steroid Injection

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