Recruiting

Local Anesthetic/Steroid

Sponsor:

Eastern Virginia Medical School

Code:

NCT05292677

Conditions

Laryngeal Nerve Block

Chronic Neurogenic Cough

Laryngeal Hypersensitivity

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Steroid/Anesthesia Mixture

Placebo

Study Details

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.

Conditions

Laryngeal Nerve Block

Chronic Neurogenic Cough

Laryngeal Hypersensitivity

Study ID

NCT05292677

Start date

Jul 21, 2021

Status verified date

Mar, 2022

Completion date

Jun 25, 2023

Anticipated

Primary completion date

Jun 25, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intervention (Steroid/Anesthetic Mixture)

The steroid/anesthetic mixture will be injected via a 27-gauge needle once at the baseline or during the 6-week crossover timepoint.

placebo comparator: Placebo (Normal Saline)

The placebo (Normal Saline) will be injected via a 27-gauge needle once at the baseline or during the 6-week crossover timepoint.

Interventions

Steroid/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.

Placebo

2 mL of Normal Saline

Primary outcome measure

  • Intervention vs. Placebo in Neurogenic Cough using Capsaicin Challenge [ Time Frame: Comparing Changes at Pretreatment, at 30 minutes post treatment, at 1 week post treatment, and at 6 weeks post treatment ]

Central Contacts and Locations

Central contacts

Addy Tham, MS

757.388.6264thama@evms.edu

Laura Stone, RN

757.388.6238stonelj@evms.edu

Locations

Eastern Virginia Medical School Ear, Nose, and Throat Surgeons

Recruiting

Norfolk, Virginia, United States, 23507

Contacts

Addy Tham, MS

757-388-6264thama@evms.edu

Laura Stone, RN

757.388.6238stonelj@evms.edu

Principal Investigator:

Benjamin Rubinstein, MD

More Information

Sponsor

Eastern Virginia Medical School

Last update posted

Mar 23, 2022

Last verified

Mar, 2022

Keywords

  • cough
  • chronic cough
  • neurogenic cough
  • laryngeal nerve block

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Eastern Virginia Medical School on 2022-03-23.