Analgesic Effect of Ultrasound Guided Maxillary Nerve Block in Trigeminal Neuralgia

Not Applicable

Withdrawn

• Conditions: Trigeminal Neuralgia
• Interventions: Procedure: US guided block of maxillary nerve

• Registration Number: NCT06129071
• Lead Sponsor: Varazdin General Hospital

Brief Summary

This is a study about the dynamics and effects of ultrasound guided maxillary nerve block in trigeminal neuralgia

Detailed Description

Standard pharmacological treatment for trigeminal neuralgia is often insufficient. In this setting, patients often suffer trough everyday activities and quality of life is disturbed substantially.

In this prospective clinical study, analgesic effect of ultrasound (US) guided maxillary nerve block will be investigated, in order to prolong pain-free time, reduce the use of standard analgesics, as well as atypical ones (e.g. antiepileptic drugs and antidepressants).

Characteristics of US guided maxillary nerve block will pain investigated: reduction of pain (decrease of VAS score), duration of pain-free period, pain level during the procedure.

Study Timeline

• Status Verified: 2023-11
• Study First Submitted: 2023-11-07
• Study First Submitted QC: 2023-11-10
• Study First Posted: 2023-11-13
• Study Start: 2023-12-01
• Last Update Submitted: 2024-04-06
• Last Update Posted: 2024-04-09
• Primary Completion: 2024-12-31
• Study Completion: 2025-03-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• patients with trigeminal neuralgia

Exclusion Criteria

• allergy to local anesthetics
• local infection at the site of needle puncture
• parotitis
• serious liver disease
• use of antiarrhythmics group III (eg amiodarone)
• anticoagulant or antithrombotic drugs
• lactation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
US block of maxillar nerve	US guided block of maxillary nerve	Extraoral ultrasound-guided block of the maxillary nerve will be performed using an ultrasound device. After visualisation of the pterygomandibular space, of the maxillary artery and the mandibular nerve next to it, at a depth of 2-4 cm, the detection of the maxillary artery is confirmed by Color Doppler. A needle enters between the coronoid and condylar processes, using the "out of plane" technique, near the maxillary artery, and after negative aspiration, local anesthetic levobupivacaine (0,5%, 2 mL) combined with triamcinolonacetonid (2mL).

Primary Outcome Measures

Name	Time	Method
Time without pain	26 weeks	Patients will report to the investigator when pain starts to rise - and the amount of time form the procedure to the reporting will be recorded

Secondary Outcome Measures

Name	Time	Method
Trend of pain level	Pain level at three time points: 1 month, 3 months and 6 months after the procedure	Pain will be graded according to visual analogue scale, 0 meaning no pain, 10 meaning the worse pain possible
Time to sart of the action of the block	Immediately after the procedure	Time from the procedure till the pain is reduced, in minutes
Pain level when anesthesia is applied	Immediately after the procedure	Pain will be graded according to visual analogue scale, 0 meaning no pain, 10 meaning the worse pain possible

Trial Locations

Locations (1)

Varazdin General Hospital; 🇭🇷 Varaždin, Croatia