Office-Based Superior Laryngeal Nerve Block for Treatment of Neurogenic Cough

Office-Based Superior Laryngeal Nerve (SLN) Block for Treatment of Neurogenic Cough

The purpose of this study is to evaluate if office-based injection of a local anesthetic/steroid combination at the area of one superior laryngeal nerve can decrease cough frequency and alleviate symptoms of chronic cough in patients with neurogenic cough.

Study Overview

• Status: Recruiting
• Conditions: Cough
• Intervention / Treatment: Drug: superior laryngeal nerve block

Detailed Description

Neurogenic cough is a chronic cough without a clear cause. It is thought to be related to irritation of a nerve that goes to the larynx (voice box). This can happen after a viral upper respiratory infection. Current treatment uses therapy or medications taken by mouth. Those medications can be sedating and not well tolerated. An alternative approach would be to perform an injection "nerve block", which is commonly done for other nerve disorders such as around the spine. This may help people with neurogenic cough also. We studied this recently in a small group of patients and found that patients had improvement in their cough symptoms (Simpson 2018). It would be helpful to study this in a larger group of patients using more methods of evaluating cough symptom severity.

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • Recruiting
      • University of Alabama at Birmingham
      • Contact: Blake Simpson, MD; Phone Number: 205-801-7864; Email: blakesimpson@uabmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients presenting to UAB Department of Otolaryngology for the evaluation and treatment of chronic cough who would be undergoing superior laryngeal nerve block as part of their standard clinical care.

Description

Inclusion Criteria:

• Age 18 years or older
• Ability of patients to speak and understand English
• Ability for patients to consent for themselves
• Cough for 8 weeks or greater, with suspected sensory neuropathic etiology of the cough. Inclusion based on history of preceding upper respiratory infection or other symptoms suggestive of irritable larynx such as cough in response to temperature changes, odors, scents/perfumes, tickle, irritation in the throat/paralaryngeal region, or talking.

• Persistent cough despite treatment of ALL the major contributors of cough (items listed below would be done as part of a standard clinical workup for chronic cough and are not done specific to this study):

  • Reflux disease treatment with one of the following: failure of two months of PPIs OR negative pH study
  • Asthma: lack of response to at least one month of steroid inhaler/bronchodilator OR normal PFTs/negative methacholine challenge + negative CXR/CT
  • Upper airway cough syndrome/Allergic disease: lack of response to at least one month of antihistamines/decongestants/nasal steroids OR negative allergy testing (skin or serum) OR lack of response to at least one year of immunotherapy/allergy shots

Exclusion Criteria:

• Age less than 18 years
• Patients unable or unwilling to provide informed consent
• Known etiology to cough other than sensory neuropathy (e.g., reflux disease, asthma, allergic rhinitis, chronic obstructive pulmonary disease)
• Addition of new neuromodulators at the time of the injection. Patients who were already being treated with neuromodulators for their cough (e.g., gabapentin, amitriptyline) will not be excluded provided their dose remains constant.
• Nissen fundoplication within the last year
• Smoking history within last 5 years
• Allergy to bupivacaine or Kenalog-40

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

SLN intervention group; Participants will undergo a superior laryngeal nerve (SLN) block

Drug: superior laryngeal nerve block; A unilateral injection of 2 cc of a 1:1 mixture of 0.25% bupivacaine and Kenalog-40 via a 27 gauge needle to the thyrohyoid space (front of neck, just above larynx/voice box) via a 27 gauge needle to the thyrohyoid space (front of neck, just above larynx/voice box) on the side which exhibited most discomfort/tenderness/cough on palpation. If neither side was uncomfortable, the right side will be used.; Other Names: 0.25% bupivacaine; Kenalog-40

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in score on the Leicester Cough Questionnaire	The Leicester Cough Questionnaire consists of 19 questions designed to assess the impact of cough on various aspects of a participant's quality of life. Scores are chosen from a Likert scale from 1 to 7, with 1 representing "all of the time" and 7 representing "none of the time." Scores would decrease if symptoms improved.	Baseline to 3 months

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2022
• Primary Completion (Anticipated): October 1, 2024
• Study Completion (Anticipated): October 1, 2026

Study Registration Dates

• First Submitted: November 19, 2020
• First Submitted That Met QC Criteria: November 19, 2020
• First Posted (Actual): November 24, 2020

Study Record Updates

• Last Update Posted (Actual): March 28, 2023
• Last Update Submitted That Met QC Criteria: March 25, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: chronic cough
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Cough; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents; Immunosuppressive Agents; Immunologic Factors; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Anesthetics, Local; Triamcinolone Acetonide; Bupivacaine
• Other Study ID Numbers: IRB-300005783

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No