The Use of Tx360™ Nasal Applicator for Sphenopalatine Ganglion Block in the Treatment of Trigeminal Neuralgia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Pain intensity numeric rating scale
研究概览
简要总结
The pain from Trigeminal Neuralgia (TN) imposes a substantial burden on patients in daily function and reduces quality of life. The sphenopalatine ganglion, located in the posterior part of the middle nasal turbinate, is involved in the pain associated to TN, by blocking the sphenopalatine ganglion relieves patients from the symptoms. However, methods currently in use to accomplish this are either cumbersome for the patient or invasive regarding the puncture of structures.
The purpose of this study is to evaluate the efficacy of Tx360™, a new nasal applicator device, in the treatment of TN. A local anesthetic will be delivered on the ganglion area. We are expecting that this new device will provide at least the same pain relief as the previously described approaches. However, this nasal applicator is intended to be an easy and non invasive method for office use.
详细描述
The pain from Trigeminal Neuralgia (TN) imposes a substantial burden on patients in daily function and reduces quality of life. Pain severity correlates with reduced measures of daily functioning, and overall health status.
The sphenopalatine ganglion, located in the posterior part of the middle nasal turbinate, is involved in the pain associated to TN, by blocking the sphenopalatine ganglion relieves patients from the symptoms. However, methods currently in use to accomplish this are either cumbersome for the patient or invasive regarding the puncture of structures.
The purpose of this study is to evaluate the efficacy of Tx360™, a new nasal applicator device, in the treatment of TN. The Tx360™ is a single use nasal applicator that can reach the sphenopalatine ganglion area. It is designed to dispense medications through a flexible canula.
The patients with TN will receive a 0.5 mL spray of local anesthetic on the ganglion area, and measure the change in pain intensity and quality of life.
We are expecting that this new device will provide at least the same pain relief as the previously described approaches. However, this nasal applicator is intended to be an easy and non invasive method for office use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18- 80 years old
- •Trigeminal Neuralgia
排除标准
- •Nasal septal deformity such as: cleft lip and palate, choanal atresia
- •Septal perforation
- •Recent nasal/midface trauma (< 3 months)
- •Bleeding disorder such as Von Willebrand's disease or hemophilia
- •Severe respiratory distress
- •Neoplasm such as the following: Angiofibroma, sinus Tumors, Granuloma
- •Congestion has been present more than 10 days, fever (define as temperature≥ 100.4 F)
- •Current cocaine user
- •Skin around and inside the nasal passage is dry, cracked, oozing, or bleeding
- •Allergy to marcaine
- •Pregnancy
研究组 & 干预措施
Nasal ganglion block for TN
Sphenopalatine ganglion block using the Tx360™ device
干预措施: Nasal ganglion block for TN (Device)
结局指标
主要结局
Pain intensity numeric rating scale
时间窗: Before procedure and after procedure
Change in pain intensity before procedure, baseline. And after procedure 15 minutes, 30 minutes, day 1, 7, 14, 21, and 28.
次要结局
- Patient's global impression of change(After procedure)
研究者
Kenneth D Candido
Chairman of the Anesthesia Department at Advocate Illinois Masonic Medical Center
Chicago Anesthesia Pain Specialists