Chronic Neurogenic Cough, Laryngeal Hypersensitivity, Laryngeal Nerve Block
Conditions
Keywords
cough, chronic cough, neurogenic cough, laryngeal nerve block
Brief summary
The purpose of this study is to study the potential benefit of treating chronic neurogenic cough by blocking the nerve responsible for the disease with an injection of local anesthetic/steroid mixture versus a placebo.
Detailed description
This study will be performed by asking participants to fill out multiple questionnaires on the symptoms of their cough, and undergo cough testing by inhaling an airway irritant and monitoring the number of coughs after inhalation of the irritant. Subjects would then undergo the treatment and have an injection of either local anesthetic/steroid mixture or a placebo (normal saline) around the nerve that gives feeling to the portion of the voice box responsible for chronic neurogenic cough. After the injection you will be asked to repeat the cough testing and questionnaires 30 minutes, 1 weeks, and at 6 weeks post injection. After the initial six weeks, patients will cross over and repeat the same process with the opposite treatment (either local anesthetic/steroid mixture or placebo) from their previous injection. The total time of participation is about 12 weeks and we hope to recruit 40 subjects.
Interventions
DRUGSteroid/Anesthesia Mixture
Steroid will be Triamcinolone Acetonide (40mg/mL). Anesthetic will be 0.5% bupivacaine with 1:100,000 epinephrine. These will be pre-mixed by a qualified personnel within the ENT department.
DRUGPlacebo
2 mL of Normal Saline
Sponsors
Eastern Virginia Medical School
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years and older * Previously or Newly Diagnosed Chronic Neurogenic Cough
Exclusion criteria
* History of Laryngeal Surgery or External Beam Radiation * Current Smokers * Known Allergy or Sensitivity to Local Anesthetics * Uncontrolled Pulmonary, SinoNasal, or GastroIntestinal Pathology leading to Refractory Chronic Cough
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intervention vs. Placebo in Neurogenic Cough using Capsaicin Challenge | Comparing Changes at Pretreatment, at 30 minutes post treatment, at 1 week post treatment, and at 6 weeks post treatment | Objectively evaluate the efficacy of blockade of the internal branch of the superior laryngeal nerve with local anesthetic/steroid mixture compared to normal saline placebo in treating chronic neurogenic cough using capsaicin challenge testing to measure cough sensitivity and urge to cough |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intervention vs. Placebo in Neurogenic Cough using the Newcastle Laryngeal Hypersensitivity Questionnaire | Pretreatment, 30 minutes post treatment, 1 week post treatment, 6 weeks post treatment | Subjectively evaluate the efficacy of superior laryngeal nerve block (intervention) vs. placebo using the Newcastle Laryngeal Hypersensitivity Questionnaire (NLHQ). This Questionnaire is scaled from 1 to 7. 1 indicates All of the Time while 7 reflects None of the Time. |
| Intervention vs. Placebo in Neurogenic Cough using the Urge to Cough Scale | Pretreatment, 30 minutes post treatment, 1 week post treatment, 6 weeks post treatment | Subjectively evaluate the efficacy of superior laryngeal nerve block (intervention) vs. placebo using the Urge to Cough Scale. Higher score indicates more urge, while lower score reflects less of an urge to cough. |
| Intervention vs. Placebo in Neurogenic Cough using the Central Sensitization Inventory | Pretreatment, 30 minutes post treatment, 1 week post treatment, 6 weeks post treatment | Subjectively evaluate the efficacy of superior laryngeal nerve block (intervention) vs. placebo using the Central Sensitization Inventory (CSI). Scale is ranked as Never, Rarely, Sometimes, Often, and Always and has various symptoms listed. |
| Quality of Life Measurements | Pretreatment, 1 week post treatment, 6 weeks post treatment | Analyze quality of life measurements of patients undergoing superior laryngeal nerve block compared to placebo as measured by the Leicester Cough Questionnaire (LCQ). Scale is from a 1 to 7. The higher the score/rating represents less of a problem while a lower score/rating represents more of a problem. |
Countries
United States
Contacts
Primary ContactAddy Tham, MS
Backup ContactLaura Stone, RN
Outcome results
None listed