Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
32 participants
INTERVENTIONAL
2021-08-01
2023-07-01
Brief Summary
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Detailed Description
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The use of local anesthetic or vibrating instrument will decrease overall pain experienced by a patient with spasmodic dysphonia undergoing Botox injections.
Aims, purpose, or objectives:
To identify adjuvant methods to improve patient comfort during in-office laryngology procedures. Results demonstrated here should be transferrable to other transcutaneous in-office procedures in laryngology.
Background:
Spasmodic dysphonia is a vocal disorder characterized by uncontrollable voice breaks. Injection of botulinum neurotoxin into the laryngeal muscles is the mainstay of treatment. Patients require repeated treatments due to the temporary effect of botulinum neurotoxin. Laryngeal injections are commonly performed through the skin of the neck and can be associated with pain and discomfort. Local anesthetic administration prior to laryngeal injection is commonly performed in clinical practice, however its efficacy hasn't been evaluated and a third of surveyed otolaryngologists do not administer local anesthesia prior to the laryngeal injection of botulinum neurotoxin. Vibratory anesthesia involves the application of a local vibratory stimulus and has been found to reduce pain during various needle-related procedures. Vibratory anesthesia has not previous been evaluated for laryngeal injections.
This study will utilize the need for spasmodic dysphonia patients to receive repeated injections to incorporate a crossover design where patients receive three consecutive laryngeal injections of botulinum toxin experiencing injection without additional anesthesia, with local anesthesia, and with vibration anesthesia in a randomized order.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Control
Patients will receive standard of care laryngeal injection of Botox via a transcricothyroid approach without additional anesthesia
No interventions assigned to this group
Lidocaine
Patients will receive standard of care laryngeal injection of Botox via a transcricothyroid approach following subcutaneous injection of lidocaine (approximately 2 minutes before Botox injection).
Lidocaine
Subcutaneous injection 0.5cc 2% in 1:100,000 epinephrine
Vibrating Wand
Patients will receive standard of care laryngeal injection of Botox via a transcricothyroid approach while using the vibrating wand.
Vibrating wand
a vibrating instrument held adjacent to the cricothyroid space
Interventions
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Lidocaine
Subcutaneous injection 0.5cc 2% in 1:100,000 epinephrine
Vibrating wand
a vibrating instrument held adjacent to the cricothyroid space
Eligibility Criteria
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Inclusion Criteria
* Receiving botox as treatment via a transcricothyroid approach
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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David G. Lott, M.D.
Principal Investigator
Principal Investigators
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David Lott, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic in Arizona
Phoenix, Arizona, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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20-006889
Identifier Type: -
Identifier Source: org_study_id
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