Efficacy of SLN Block for Chronic Cough

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-22

Study Completion Date

2022-12-30

Brief Summary

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This is a research study to find out if superior laryngeal nerve blocks are an effective way to reduce cough when compared to placebo (a substance without any medical value). Eligibility for the study include the following: age \>18, cough history suggestive that the nerve to the voice box is overactive, non-smoker, Patients will be followed over time and assigned to either the treatment or placebo group at random. The treatment would be four superior laryngeal nerve blocks and the placebo would be four saline injections (the inactive substance). Study team will measure if the injection improved cough and ask patients to keep a log of symptoms and fill out questionnaires at each visit. After the four injections, patients will follow up in 3 months to see if cough has returned and if so, how severe the cough is.

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Detailed Description

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Conditions

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Cough Superior Laryngeal Nerve Block Neurogenic Cough

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two treatment arms:

1. Treatment Group (n=25) - 2 mL of 1:1 triamcinolone 40:1% lidocaine with 1:2000000 epinephrine.
2. Placebo group (n=25) 2 mL of saline.

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

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Steroid-Lidocaine Mixture

Will receive numbing injection, which is a mixture of steroid and lidocaine

Group Type EXPERIMENTAL

Superior laryngeal nerve block

Intervention Type PROCEDURE

Injection of either the steroid-lidocaine mixture or placebo through the skin around where the superior laryngeal nerve is located on the neck. The procedure lasts 5 minutes and is done in the clinic.

Injection of steroid-lidocaine mixture

Intervention Type PROCEDURE

Superior laryngeal nerve block using 1mg 1:1 triamcinolone 40mg: 1% lidocaine with 1:200000 epinephrine as the injection.

Placebo

Will receive saline injection as a placebo

Group Type PLACEBO_COMPARATOR

Superior laryngeal nerve block

Intervention Type PROCEDURE

Injection of either the steroid-lidocaine mixture or placebo through the skin around where the superior laryngeal nerve is located on the neck. The procedure lasts 5 minutes and is done in the clinic.

Injection of placebo (saline)

Intervention Type PROCEDURE

Superior laryngeal nerve block using 1mL of saline as the injection.

Interventions

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Superior laryngeal nerve block

Injection of either the steroid-lidocaine mixture or placebo through the skin around where the superior laryngeal nerve is located on the neck. The procedure lasts 5 minutes and is done in the clinic.

Intervention Type PROCEDURE

Injection of placebo (saline)

Superior laryngeal nerve block using 1mL of saline as the injection.

Intervention Type PROCEDURE

Injection of steroid-lidocaine mixture

Superior laryngeal nerve block using 1mg 1:1 triamcinolone 40mg: 1% lidocaine with 1:200000 epinephrine as the injection.

Intervention Type PROCEDURE

Other Intervention Names

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Injection of steroid-lidocaine mixture vs. placebo (saline) 1mL of saline as the injection 1mg 1:1 triamcinolone 40mg: 1% lidocaine with 1:200000 epinephrine as the injection.

Eligibility Criteria

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Inclusion Criteria

* History consistent with neurogenic cough

Exclusion Criteria

* Age ≥ 18

* Current neuromodulating medication use
* Untreated other etiologies of cough:

Current smoker Current ACE/ARB use Abnormal PFTs within 6 months Uncontrolled OSA Abnormal CXR within 6 months RSI \> 13 or RFS \>11 AND workup positive for GERD (esophagram, 24-hour pH probe, manometry, EGD)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes