Recruiting
Phase 3

Superior Laryngeal Nerve Block

Sponsor:

University of South Florida

Code:

NCT04468542

Conditions

Cough

Nerve Block

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Superior laryngeal nerve block - Intervention (Bupivacaine and triamcinolone acetonide suspension)

Superior laryngeal nerve block - Placebo (saline)

Study Details

Brief summary:

Prospective randomized placebo-controlled trial assessing the efficacy of superior laryngeal nerve block for adults with neurogenic cough refractory to proton pump inhibitor as determined by improvement in validated cough severity questionnaires before and after injection of Marcaine and Kenalog compared to placebo (saline injection).

Conditions

Cough

Nerve Block

Study ID

NCT04468542

Start date

Jan 12, 2021

Status verified date

Nov, 2022

Completion date

Dec, 2022

Anticipated

Primary completion date

Dec, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • English speaking adults referred into or treated by the University of South Florida department of Otolaryngology practice with chronic cough (including throat clearing with globus) as determined by presence > 8 weeks duration
  • Presumed to have neurogenic component based on history with no other obvious treatable (and untreated) cause
  • refractory to proton pump inhibitor (PPI) therapy (at least 4 week trial)
  • no improvement of upper airway cough syndrome symptoms with medications if indicated (eg, Flonase and antihistamine)
  • Patients may continue any medications for possibly related conditions (e.g., Flonase, gabapentin, etc.) including allergies, chronic sinusitis, acid reflux; there should be NO changes to mediation regimen within 1 months of study initiation (with the exception of patients who were not previously on PPI that failed trail of PPI which they will discontinue 1 month prior to first intervention)
  • Willingness to participant be assigned and adhere to the protocol. Participants must be willing and able to consent to participate in the study, be willing to undergo intervention or the placebo, and be willing to commit to adhere to the study protocol for the duration of the trial (PPI trial if applicable, 2-4 visits, follow up questionnaires, participate in cough suppression)

Exclusion Criteria:

  • unwilling to participate in protocol
  • allergic to Marcaine/lidocaine or predisposing condition to allergy
  • uncontrolled medical condition (this will be treated on a case by case basis using clinical judgment of risks and the medical condition, with participants being excluded who have conditions that may significantly increase the odds of having a serious or life-threatening reaction)
  • pulmonary processes (including chronic obstructive pulmonary disease (chronic obstructive pulmonary disease), bronchiectasis, non-asthmatic eosinophilic bronchitis, structural abnormalities, etc.)
  • asthma (must have history of abnormal pulmonary function provocation testing)
  • structural abnormality laryngoscopy (this does not pertain to inflammatory findings)
  • immunocompromised
  • current smoker (>1 cigarette in past month)
  • use of angiotensin converting enzyme inhibitor current or within past month
  • Vulnerable population: students, employees, socially or economically disadvantaged, wards of the state, pregnant women, cognitively impaired adults, non-adults.

Study Design

Enrollment

65 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Bupivacaine/triamcinolone injection

2-cc injection (mixture consisting of 1-cc of 0.5% Bupivacaine injection and 1cc of 40mg/cc triamcinolone acetonide suspension injection) will be delivered percutaneously into the region of the proximal superior laryngeal nerve, every 1-2 weeks, for total of 2 to 3 injections

placebo comparator: Saline injection

2-cc injection of normal saline will be delivered percutaneously into the region of the proximal superior laryngeal nerve, every 1-2 weeks, for total of 2 to 3 injections

Interventions

Superior laryngeal nerve block - Intervention (Bupivacaine and triamcinolone acetonide suspension)

2-cc injection (mixture consisting of 1-cc of 0.5% Bupivacaine injection and 1cc of 40mg/cc triamcinolone acetonide suspension injection) will be delivered percutaneously into the region of the proximal superior laryngeal nerve, every 1-2 weeks, for total of 2 to 3 injections

Superior laryngeal nerve block - Placebo (saline)

2-cc injection of saline will be delivered percutaneously into the region of the proximal superior laryngeal nerve, every 1-2 weeks, for total of 2 to 3 injections

Primary outcome measure

  • 2 week post-treatment cough severity index score improvement [ Time Frame: Immediately pre-treatment and post-treatment at 2 weeks ]
  • 2 week post-treatment cough-specific quality-of-life questionnaire score improvement [ Time Frame: Immediately pre-treatment and post-treatment at 2 weeks ]

Central Contacts and Locations

Central contacts

Anthony J Grady, MD

(813) 974-5638agrady@usf.edu

Locations

University of South Florida South Tampa Clinic

Recruiting

Tampa, Florida, United States, 33612

Contacts

Anthony Grady, MD

813-974-4683agrady@usf.edu

More Information

Sponsor

University of South Florida

Last update posted

Nov 8, 2022

Last verified

Nov, 2022

Keywords

  • Superior laryngeal nerve
  • Neurogenic cough
  • Nerve Block
  • Idiopathic cough

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of South Florida on 2022-11-08.