Randomized Placebo-controlled Analysis of Superior Laryngeal Nerve Block for Neurogenic Cough

• Status: Recruiting
• Trial end date: 2021-10-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of South Florida
• Treatments: Bupivacaine; Triamcinolone; Triamcinolone Acetonide; Triamcinolone diacetate; Triamcinolone hexacetonide

Criteria

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.