Sphenopalatine Ganglion Block with Tx360 for Trigeminal Neuralgia

NCT06663410 | Completed DMC

• 2 other identifiers: 274/12-11-2020Aretaieio Hospital
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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).

Conditions

Trigeminal Neuralgia

Keywords

Trigeminal Neuralgia; SPG block; Tx360; nasal applicator

Outcome Measures

Primary Outcomes (1)

• NRS pain score

  Outcome measures were assessed on a weekly basis for the initial 6-week treatment period, that is at every visit where SPG block would be administered, and on a monthly basis for the subsequent 12-week follow-up period, where patients participated in scheduled monthly follow-up calls. Patients were instructed to maintain a detailed pain diary for these 18 weeks and were asked about their pain intensity as measured with the Numerical Rating Scale (NRS) scoring system. NRS consists of a simple 11-point scale from zero to ten, where zero corresponds to non-existent pain and ten corresponds to the worst possible pain the patient has ever experienced. Patients choose the number that best corresponds to the intensity of their pain.

  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 (1)

• changes in the 9 components measured by the SF-36 questionnaire

  during the first visit to the clinic and 3 months after the completion of the treatment

Study Arms (1)

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.

Device: SPG block with the use of the Tx360 device

Interventions

SPG block with the use of the Tx360 device 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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aretaieio Hospital: lead

Study Sites (1)

Aretaieio Hospital, National and Kapodistrian University of Athens

Athens, 11528, Greece

Location

Related Publications (4)

• 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.

  PMID: 25338927 BACKGROUND

• 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.

  PMID: 24284858 BACKGROUND

• 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.

  PMID: 29285576 BACKGROUND

• 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.

  PMID: 21956040 BACKGROUND

MeSH Terms

Conditions

Trigeminal Neuralgia

Condition Hierarchy (Ancestors)

Trigeminal Nerve Diseases; Facial Neuralgia; Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Diseases; Nervous System Diseases

Study Officials

• Athanasia Tsaroucha, Assoc. Prof.

  Aretaieio Hospital, National and Kapodistrian University of Athens

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident anesthesiologist, MD, MSc

Study Record Dates

• First Submitted: October 24, 2024
• First Posted: October 29, 2024
• Study Start: February 28, 2021
• Primary Completion: April 15, 2024
• Study Completion: April 15, 2024
• Last Updated: October 29, 2024

Record last verified: 2024-10

Locations

GR (1)