Clinical trial NCT06129071: Analgesic Effect of Ultrasound Guided Maxillary Nerve Block in Trigeminal Neuralgia
Official title: Analgesic Effect Evaluation of Ultrasound Guided Maxillary Nerve Block in Trigeminal Neuralgia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Trigeminal Neuralgia
Keywords: trigeminal neuralgia
maxillary nerve
ultrasound guided nerve block
Lead sponsor: Varazdin General Hospital
Sponsor class: OTHER
First posted: 2023-11-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Time without pain
timeFrame: 26 weeks
Secondary outcomes:
measure: Trend of pain level
timeFrame: Pain level at three time points: 1 month, 3 months and 6 months after the procedure
measure: Pain level when anesthesia is applied
timeFrame: Immediately after the procedure
measure: Time to sart of the action of the block
timeFrame: Immediately after the procedure
Other outcomes:
Locations:
city: Varaždin
country: Croatia
facility: Varazdin General Hospital
Study officials:
affiliation: Varazdin General Hospital
name: Monika Kocman Panic
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Balta S, Koknel Talu G. Clinical effectiveness of peripheral nerve blocks with lidocaine and corticosteroid in patients with trigeminal neuralgia. Agri. 2021 Oct;33(4):237-242. doi: 10.14744/agri.2021.26032.
citation: Ertilav E, Aydin ON. Evaluation of the effectiveness duration of peripheral blocks applied with high concentration local anesthetic and steroid in trigeminal neuralgia. Agri. 2022 Oct;34(4):264-271. doi: 10.14744/agri.2021.77854.
citation: Kumar A, Sinha C, Kumar A, Kumari P, Mukul SK. Ultrasound-guided trigeminal nerve block and its comparison with conventional analgesics in patients undergoing faciomaxillary surgery: Randomised control trial. Indian J Anaesth. 2018 Nov;62(11):871-875. doi: 10.4103/ija.IJA_256_18.
citation: Gunes A, Bulut E, Akgoz A, Mocan B, Gocmen R, Oguz KK. Trigeminal nerve and pathologies in magnetic resonance imaging - a pictorial review. Pol J Radiol. 2018 Jun 16;83:e289-e296. doi: 10.5114/pjr.2018.76921. eCollection 2018.
citation: Jacques N, Karoutsos S, Marais L, Nathan-Denizot N. Quality of life after trigeminal nerve block in refractory trigeminal neuralgia: A retrospective cohort study and literature review. J Int Med Res. 2022 Oct;50(10):3000605221132027. doi: 10.1177/03000605221132027.