Clinical trial NCT06663410: Sphenopalatine Ganglion Block with Tx360 for Trigeminal Neuralgia
Official title: Sphenopalatine Ganglion Block with Tx360 Nasal Applicator for Trigeminal Neuralgia: a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Trigeminal Neuralgia
Keywords: Trigeminal Neuralgia
SPG block
Tx360
nasal applicator
Lead sponsor: Aretaieio Hospital
Sponsor class: OTHER
First posted: 2024-10-29
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients of both sexes, ASA I or II, with classical or atypical, V2 (maxillary branch) or V3 (mandibular branch) trigeminal neuralgia, partly or completely drug-resistant, with NRS = 8-9, under pharmaceutical treatment, with minimal or no clinical improvement and/or poor patient satisfaction. A written informed consent was obtained from each eligible patient.

Brief summary: 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).

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: NRS pain score
timeFrame: From enrollment to the end of the follow-up period, which included an initial 6-week period, where the treatment was being administered, and a subsequent 12-week period post-treatment that served for follow-up purposes.
Secondary outcomes:
measure: changes in the 9 components measured by the SF-36 questionnaire
timeFrame: during the first visit to the clinic and 3 months after the completion of the treatment
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Aretaieio Hospital, National and Kapodistrian University of Athens
Study officials:
affiliation: Aretaieio Hospital, National and Kapodistrian University of Athens
name: Athanasia Tsaroucha, Assoc. Prof.
role: STUDY_DIRECTOR
References:
citation: Cady R, Saper J, Dexter K, Manley HR. A double-blind, placebo-controlled study of repetitive transnasal sphenopalatine ganglion blockade with tx360((R)) as acute treatment for chronic migraine. Headache. 2015 Jan;55(1):101-16. doi: 10.1111/head.12458. Epub 2014 Oct 23.
citation: Candido KD, Massey ST, Sauer R, Darabad RR, Knezevic NN. A novel revision to the classical transnasal topical sphenopalatine ganglion block for the treatment of headache and facial pain. Pain Physician. 2013 Nov-Dec;16(6):E769-78.
citation: Ho KWD, Przkora R, Kumar S. Sphenopalatine ganglion: block, radiofrequency ablation and neurostimulation - a systematic review. J Headache Pain. 2017 Dec 28;18(1):118. doi: 10.1186/s10194-017-0826-y.
citation: Piagkou M, Demesticha T, Troupis T, Vlasis K, Skandalakis P, Makri A, Mazarakis A, Lappas D, Piagkos G, Johnson EO. The pterygopalatine ganglion and its role in various pain syndromes: from anatomy to clinical practice. Pain Pract. 2012 Jun;12(5):399-412. doi: 10.1111/j.1533-2500.2011.00507.x. Epub 2011 Sep 29.