Sphenopalatine Ganglion Block with Tx360 for Trigeminal Neuralgia

Aretaieio Hospital

Status: Completed

Conditions: Trigeminal Neuralgia

Treatments: Device: SPG block with the use of the Tx360 device

Study type: Observational

Funder types: Other

Identifiers

NCT06663410

Aretaieio Hospital (Other Identifier)

274/12-11-2020

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

15 participants in 1 patient group

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

Description:

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.

Treatment:

Device: SPG block with the use of the Tx360 device