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Trigeminal Neuralgia, IdiopathicGLOA-MRTNCT05257655

Ganglionic Local Opioid Analgesia at the Ganglion Cervicale Superius

A study testing MRI after ganglionic local opioid analgesia (GLOA) in people with Trigeminal Neuralgia, Idiopathic and Postherpetic; Neuralgia, Trigeminal (Etiology), run by Klinikum Klagenfurt am Wörthersee at 1 site in Austria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The blockade of the superior cervical ganglion (GCS) of the sympathetic trunk is a very special form of therapy. The transoral blocking technique, also known as GLOA (ganglionic local opioid analgesia), is very suitable for achieving GCS. A total of 5 μg of sufentanil in 2 ml of sodium chlorid are applied. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
MRI after ganglionic local opioid analgesia (GLOA)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
1 siteAustria
Study dates
9 Jan 2023to 1 Oct 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Trigeminal neuralgia
  • Postherpetic neuralgia
  • Glossopharyngeal neuralgia
  • Atypical facial pain

Who cannot join

  • psychosis
  • language barrier
  • Pregnant and breastfeeding women
  • Seizure disorders (epilepsy)
  • Increased risk of bleeding

Trial locations and contacts

1 site in 1 country.

Austria1 site

  • Klinikum Klagenfurt am Wörthersee

    Klagenfurt, 9020

Other trials in Austria

About this study

Official title: MRI Observation After Ganglionic Local Opioid Analgesia at the Ganglion Cervicale Superius

The blockade of the superior cervical ganglion (GCS) of the sympathetic trunk is a very special form of therapy. The transoral blocking technique, also known as GLOA (ganglionic local opioid analgesia), is very suitable for achieving GCS. A total of 5 μg of sufentanil in 2 ml of sodium chlorid are applied.

Since no imaging evidence of the injected substances has been published for a GLOA in a living person, it is planned to carry out an MRI examination immediately after the ganglionic local opioid analgesia in order to show the spread and distribution pattern of the injected substance. It is also planed to show a correlation of the spread of the injected substance with the efficacy of the intervention.

Read more

To determine the interrater reliability, the GLOA is carried out alternately by 2 different examiners and the existing MRI images of the GLOA are assessed by an radiologist and anatomist in a blinded manner.

In a follow-up after 1 and 3 months, the questionnaires and pain scores are evaluated again.

Read the detailed description

The blockade of the superior cervical ganglion (GCS) of the sympathetic trunk is a very special form of therapy. It is successfully used for numerous, often protracted diseases that severely impair the patient's quality of life, such as idiopathic facial pain syndromes or trigeminal neuralgia. The transoral blocking technique, also known as GLOA (ganglionic local opioid analgesia), is very suitable for achieving GCS. With this technique, a Sprotte cannula is inserted into the pharyngeal recess (Rosenmueller) located behind the palatopharyngeal arch and pierced through the pharyngeal wall into the parapharyngeal space. A total of 5 μg of sufentanil in 2 ml of sodium chlorid are applied.

Since no imaging evidence of the injected substances has been published for a GLOA in a living person, it is planned to carry out an MRI examination immediately after the ganglionic local opioid analgesia in order to show the spread and distribution pattern of the injected substance. It is also planed to show a correlation of the spread of the injected substance with the efficacy of the intervention. For this, different questionnaires (NRS, quality of life, sleep quality, patient satisfaction) are carried out before and after the intervention.

To determine the interrater reliability, the GLOA is carried out by 2 different examiners and the existing MRI images of the GLOA are assessed by an radiologist and anatomist in a blinded manner.

In a follow-up after 1 and 3 months, the questionnaires and pain scores are evaluated again.

Being tested
MRI after ganglionic local opioid analgesia (GLOA)
Keywords
GLOA, MRI,
Medical subject headings
Trigeminal Neuralgia, Neuralgia, Glossopharyngeal Nerve Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MRI after ganglionic local opioid analgesia (GLOA)Procedure or surgery

    Also called MRI

    MRI after Ganglionic Local Opioid Analgesia at the Ganglion Cervicale Superius

Study groups in NCT05257655
Study groupRoleWhat they receive
InterventionOtherMRI after Ganglionic Local Opioid Analgesia at the Ganglion Cervicale Superius;
Receives: Procedure: MRI after ganglionic local opioid analgesia (GLOA)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Distribution of the injected fluid in the area of the superior cervical ganglion

    MRI verified distribution of the injected fluid in the area of the superior cervical ganglion

    Measured: immediately after the intervention

Secondary outcomes (5)

  1. Quality of life questionnaire

    The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state (https://euroqol.org/eq-5d-instruments/eq-5d-5l-about/)

    Measured: Before first and after last GLOA. After 1 and 3 month (follow up)

  2. Pain assessed by NRS

    Present pain intensity on a 0-10 Numerical Rating Scale (NRS) with 0 corresponding to "no pain" and 10 to "the worst pain imaginable

    Measured: baseline, immediately after intervention, After 1 and 3 month (follow up)

  3. Patient satisfaction assessed by satisfaction questionaire

    ZUF-8 is a measuring instrument for the global, one-dimensional recording of patient satisfaction. It is the German-language adaptation of the American CSQ-8 by Attkisson \& Zwick (1982). General satisfaction ("general satisfaction") with aspects of the clinic or the treatment received is recorded using eight items. ZUF-8 is particularly suitable for an economical screening of patient satisfaction.

    Measured: Before first and after last GLOA. After 1 and 3 month (follow up)

  4. Sleep quality assessed by sleep quality questionnaire

    To record the sleep quality the questionnaire on sleep quality is carried out (PSQI)

    Measured: Before first and after last GLOA. After 1 and 3 month (follow up)

  5. Efficacy prediction based on MRI verified fluid spread

    Efficacy prediction based on the MRI verified fluid spread in millimeter in the area of the superior cervical ganglion

    Measured: immediately after the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Feb 2022
  2. Study start9 Jan 2023
  3. Primary completion31 Aug 2023
  4. Study completion1 Oct 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Model description
Single treatment group.
Masking
None (open label)
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05257655
Sponsor's protocol ID
0815-2021
Acronym
GLOA-MRT
Status last verified
Oct 2023
First submitted
31 Jan 2022
Last updated
3 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Feigl G, Rosmarin W, Likar R. [Block of the superior cervical ganglion of the Truncus sympathicus. Why it often is not possible!]. Schmerz. 2006 Aug;20(4):277-80, 282-4. doi: 10.1007/s00482-005-0435-6. German.

    PubMed 16142462

  • Spacek A, Bohm D, Kress HG. Ganglionic local opioid analgesia for refractory trigeminal neuralgia. Lancet. 1997 May 24;349(9064):1521. doi: 10.1016/S0140-6736(05)62101-0. No abstract available.

    PubMed 9167469

  • Neuwersch-Sommeregger S, Kostenberger M, Sandner-Kiesling A, Furstner M, Igerc I, Trummer B, Wuntschek J, Pipam W, Stettner H, Likar R, Feigl G. Ganglionic Local Opioid Analgesia at the Superior Cervical Ganglion: MRI-Verified Solution Spread. Pain Ther. 2024 Jun;13(3):663-678. doi: 10.1007/s40122-024-00596-4. Epub 2024 Apr 25.

    PubMed 38662320

Questions about this trial

What is this clinical trial studying?

A study testing MRI after ganglionic local opioid analgesia (GLOA) in people with Trigeminal Neuralgia, Idiopathic and Postherpetic; Neuralgia, Trigeminal (Etiology), run by Klinikum Klagenfurt am Wörthersee at 1 site in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Distribution of the injected fluid in the area of the superior cervical ganglion (time frame: immediately after the intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05257655, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2023.

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