Sphenopalatine Ganglion Block with Tx360 for Trigeminal Neuralgia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-28

Study Completion Date

2024-04-15

Brief Summary

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The aim of this study was to investigate the effect of sphenopalatine ganglion (SPG) block bilaterally through a nasal device called Tx360 by delivering 0.3cc of lidocaine 2% for pain relief in patients with Trigeminal Neuralgia (TN).

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Detailed Description

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Trigeminal neuralgia (TN) is a chronic condition that causes sudden, intense facial pain that has a severe impact on patients' life quality and everyday functioning. Even with many treatments available, some patients still struggle to manage their pain effectively.

Sphenopalatine ganglion (SPG) block, delivered through a recently introduced nasal applicator called Tx360, has shown promising results for those patients suffering persistent facial pain, icluding cases of TN.

The purpose of this study was to observe how effective the SPG block delivering lidocaine 2% via the Tx360 is for pain relief in patients with TN. The patients' diagnosis included classical or atypical TN affecting the V2 (maxillary) or V3 (mandibular) branches, with partial or complete resistance to medication.

Researchers measured pain levels using the Numerical Rating Scale (NRS) and evaluated the effects of treatment on patients' physical and mental wellbeing using the Short Form-36 (SF-36) Quality of Life Questionnaire.

Conditions

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Trigeminal Neuralgia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Fifteen patients of both sexes, older than 18 years, ASA I or II, TN of any etiology

Patients will undergo bilateral sphenopalatine ganglion block with Tx360 nasal applicator using 0.3cc lidocaine 2% in each side, once every week, for a 6-week period.

SPG block with the use of the Tx360 device

Intervention Type DEVICE

A SPG block was performed using the Tx360 nasal applicator according to the manufacturer's instructions bilaterally, injecting 0.3cc of lidocaine 2% into each nostril.

Interventions

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SPG block with the use of the Tx360 device

A SPG block was performed using the Tx360 nasal applicator according to the manufacturer's instructions bilaterally, injecting 0.3cc of lidocaine 2% into each nostril.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* male or female
* older than 18 years
* ASA I or II
* trigeminal neuralgia of any etiology

Exclusion Criteria

* anatomical abnormalities of the nasal septum,
* rhinitis or nasal inflammation due to medication,
* nasal septum perforation,
* nasal or paranasal sinus surgery (within the last 3 months)
* dryness or irritation of the nasal mucosa, localized pain, nasal discharge, or bleeding from the nose,
* disorders related to bleeding or coagulation,
* significant respiratory distress,
* presence of malignancies, including angiofibroma or other tumors of the paranasal sinuses, or granulomas,
* persistent nasal congestion lasting more than 10 days, accompanied by high fever, discolored nasal mucosa, or facial pain and headaches,
* nasal or skull fractures occurring within the last 3 months

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No