A Nasal Applicator for the Treatment of Trigeminal Neuralgia

Trigeminal Neuralgia Clinical Trial

Official title:

The Use of Tx360™ Nasal Applicator for Sphenopalatine Ganglion Block in the Treatment of Trigeminal Neuralgia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01761604
• Other study ID #: Advocate-IRB-5241
• Status: Completed
• Phase: N/A
• First received: January 2, 2013
• Last updated: September 13, 2017
• Start date: December 2011
• Est. completion date: September 2017

Study information

• Verified date: September 2017
• Source: Chicago Anesthesia Pain Specialists
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Neuralgia
• Trigeminal Neuralgia

Intervention

Device:
• Nasal ganglion block for TN

Locations

Country	Name	City	State
United States	Chicago Anesthesia Pain Specialists	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Chicago Anesthesia Pain Specialists

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Modified Brief Pain inventory (short form)	Before procedure, baseline. And after procedure day 1, 7, 14, 21, and 28.	Before procedure and after procedure
Primary	Pain intensity numeric rating scale	Change in pain intensity before procedure, baseline. And after procedure 15 minutes, 30 minutes, day 1, 7, 14, 21, and 28.	Before procedure and after procedure
Secondary	Patient's global impression of change	Before procedure, baseline. And after procedure 30 minutes, day 1, 7, 14, 21, and 28.	After procedure