Analgesic Effect of Ultrasound Guided Maxillary Nerve Block in Trigeminal Neuralgia

April 6, 2024 updated by: Varazdin General Hospital

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

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Croatia
      • Varaždin, Croatia, 42000
        • Varazdin General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time without pain
Time Frame: 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
26 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Varazdin General Hospital

Investigators

  • Principal Investigator: Monika Kocman Panic, Varazdin General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2023

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

November 7, 2023

First Submitted That Met QC Criteria

November 10, 2023

First Posted (Actual)

November 13, 2023

Study Record Updates

Last Update Posted (Actual)

April 9, 2024

Last Update Submitted That Met QC Criteria

April 6, 2024

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20061988

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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