Prospective, Single-Blind Randomized Trial of in Office Superior Laryngeal Nerve Block for the Treatment of Chronic Neurogenic Cough
试验速览
- 阶段
- 4 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Intervention vs. Placebo in Neurogenic Cough using Capsaicin Challenge
研究概览
简要总结
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.
详细描述
This study will be performed by asking participants to fill out multiple questionnaires on the symptoms of their cough, and undergo cough testing by inhaling an airway irritant and monitoring the number of coughs after inhalation of the irritant. Subjects would then undergo the treatment and have an injection of either local anesthetic/steroid mixture or a placebo (normal saline) around the nerve that gives feeling to the portion of the voice box responsible for chronic neurogenic cough. After the injection you will be asked to repeat the cough testing and questionnaires 30 minutes, 1 weeks, and at 6 weeks post injection. After the initial six weeks, patients will cross over and repeat the same process with the opposite treatment (either local anesthetic/steroid mixture or placebo) from their previous injection. The total time of participation is about 12 weeks and we hope to recruit 40 subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years and older
- •Previously or Newly Diagnosed Chronic Neurogenic Cough
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Steroid/Anesthesia Mixture (Drug)
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.
干预措施: Placebo (Drug)
结局指标
主要结局
Intervention vs. Placebo in Neurogenic Cough using Capsaicin Challenge
时间窗: Comparing Changes at Pretreatment, at 30 minutes post treatment, at 1 week post treatment, and at 6 weeks post treatment
Objectively evaluate the efficacy of blockade of the internal branch of the superior laryngeal nerve with local anesthetic/steroid mixture compared to normal saline placebo in treating chronic neurogenic cough using capsaicin challenge testing to measure cough sensitivity and urge to cough
次要结局
- Intervention vs. Placebo in Neurogenic Cough using the Urge to Cough Scale(Pretreatment, 30 minutes post treatment, 1 week post treatment, 6 weeks post treatment)
- Intervention vs. Placebo in Neurogenic Cough using the Central Sensitization Inventory(Pretreatment, 30 minutes post treatment, 1 week post treatment, 6 weeks post treatment)
- Quality of Life Measurements(Pretreatment, 1 week post treatment, 6 weeks post treatment)
- Intervention vs. Placebo in Neurogenic Cough using the Newcastle Laryngeal Hypersensitivity Questionnaire(Pretreatment, 30 minutes post treatment, 1 week post treatment, 6 weeks post treatment)
研究者
Benjamin J Rubinstein
Assistant Professor
Eastern Virginia Medical School