Clinical trial NCT01761604: A Nasal Applicator for the Treatment of Trigeminal Neuralgia
Official title: The Use of Tx360™ Nasal Applicator for Sphenopalatine Ganglion Block in the Treatment of Trigeminal Neuralgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trigeminal Neuralgia
Lead sponsor: Chicago Anesthesia Pain Specialists
Sponsor class: OTHER
First posted: 2013-01-07
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain intensity numeric rating scale
timeFrame: Before procedure and after procedure
Secondary outcomes:
measure: Patient's global impression of change
timeFrame: After procedure
Other outcomes:
measure: Modified Brief Pain inventory (short form)
timeFrame: Before procedure and after procedure
Locations:
city: Chicago
country: United States
facility: Chicago Anesthesia Pain Specialists
state: Illinois
Study officials:
affiliation: Chicago Anesthesia Pain Specialists
name: Kenneth D Candido, M.D.
role: PRINCIPAL_INVESTIGATOR
References: