Overview

This trial is active, not recruiting.

Condition trigeminal neuralgia
Treatment nasal ganglion block for tn
Sponsor Chicago Anesthesia Pain Specialists
Start date December 2011
End date December 2016
Trial size 10 participants
Trial identifier NCT01761604, Advocate-IRB-5241

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Other)
Sphenopalatine ganglion block using the Tx360™ device
nasal ganglion block for tn

Primary Outcomes

Measure
Pain intensity numeric rating scale
time frame: Before procedure and after procedure

Secondary Outcomes

Measure
Patient's global impression of change
time frame: After procedure

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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

Additional Information

Official title The Use of Tx360™ Nasal Applicator for Sphenopalatine Ganglion Block in the Treatment of Trigeminal Neuralgia
Principal investigator Kenneth D Candido, M.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Chicago Anesthesia Pain Specialists.