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Completed

NCT Number: NCT06663410

Sphenopalatine Ganglion Block with Tx360 for Trigeminal Neuralgia

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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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Aretaieio Hospital, National and Kapodistrian University of Athens

Athens, 11528, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. NRS pain score

    Time frame: 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.

    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.

Secondary outcomes

  1. changes in the 9 components measured by the SF-36 questionnaire

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

    The SF-36 Quality of Life Questionnaire consists of 36 closed-ended questions, with 2-5 ratings in the answers. Each question contributes to a total score ranging from 0 to 100, measuring both mental and physical health status. This questionnaire is appropriate for self-completion as well as for completion during a telephone or a face-to-face interview, provided that the participant is over 14 years old.

    During the patients' first clinic appointment, they were asked to complete the SF-36 Questionnaire to assess the impact of trigeminal neuralgia on their daily functioning. Three months after the treatment was completed, we conducted a follow-up assessment using the same questionnaire in order to evaluate any changes in the nine components of the SF-36 questionnaire: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, general health, and perceived health change.

Sponsors and collaborators

Lead sponsor

Aretaieio Hospital

Other

Registry information

Official study title

Sphenopalatine Ganglion Block with Tx360 Nasal Applicator for Trigeminal Neuralgia: a Prospective Observational Study

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Oct 29, 2024
Registry last updated
Oct 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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