Analgesic Effect of Ultrasound Guided Maxillary Nerve Block in Trigeminal Neuralgia

Sponsor

Varazdin General Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06129071

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Trigeminal Neuralgia	Procedure: US guided block of maxillary nerve	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Analgesic Effect Evaluation of Ultrasound Guided Maxillary Nerve Block in Trigeminal Neuralgia

Anticipated Study Start Date :

Dec 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Mar 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: US block of maxillar 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).	Procedure: US guided block of maxillary nerve Extraoral ultrasound-guided block of the maxillary nerve will be performed in the examined group using an ultrasound device and local anesthetic levobupivacaine (0,5%, 2 mL) combined with triamcinolonacetonid (2mL).

Arm

Intervention/Treatment

Experimental: US block of maxillar 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).

Procedure: US guided block of maxillary nerve

Extraoral ultrasound-guided block of the maxillary nerve will be performed in the examined group using an ultrasound device and local anesthetic levobupivacaine (0,5%, 2 mL) combined with triamcinolonacetonid (2mL).

Outcome Measures

Primary Outcome Measures

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

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
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
Time to sart of the action of the block [Immediately after the procedure]
Time from the procedure till the pain is reduced, in minutes

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Varazdin General Hospital	Varaždin		Croatia	42000

Sponsors and Collaborators

Varazdin General Hospital

Investigators

Principal Investigator: Monika Kocman Panic, Varazdin General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Varazdin General Hospital

ClinicalTrials.gov Identifier:

NCT06129071

Other Study ID Numbers:

20061988

First Posted:

Nov 13, 2023

Last Update Posted:

Nov 13, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Varazdin General Hospital

trigeminal neuralgia

maxillary nerve

ultrasound guided nerve block

Additional relevant MeSH terms:

Trigeminal Neuralgia

Neuralgia

Study Results

No Results Posted as of Nov 13, 2023