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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01761604
Other study ID # Advocate-IRB-5241
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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