Trigeminal Neuralgia
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICENasal ganglion block for TN
Sponsors
Chicago Anesthesia Pain Specialists
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 18- 80 years old * Trigeminal Neuralgia
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity numeric rating scale | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient's global impression of change | After procedure | Before procedure, baseline. And after procedure 30 minutes, day 1, 7, 14, 21, and 28. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Modified Brief Pain inventory (short form) | Before procedure and after procedure | Before procedure, baseline. And after procedure day 1, 7, 14, 21, and 28. |
Countries
United States
Outcome results
None listed