CompletedNot Applicable

Sphenopalatine Ganglion Block with Tx360 for Trigeminal Neuralgia

Greece15 participantsStarted 2021-02-28

Plain-language 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).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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.

Trial details

NCT IDNCT06663410

SponsorAretaieio Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-04-15

View on ClinicalTrials.gov More Trigeminal Neuralgia trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.