Clinical trial NCT05257655: Ganglionic Local Opioid Analgesia at the Ganglion Cervicale Superius
Official title: MRI Observation After Ganglionic Local Opioid Analgesia at the Ganglion Cervicale Superius
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trigeminal Neuralgia, Idiopathic
Postherpetic; Neuralgia, Trigeminal (Etiology)
Glossopharyngeal Neuralgia
Atypical Facial Pain
Keywords: GLOA, MRI,
Lead sponsor: Klinikum Klagenfurt am Wörthersee
Sponsor class: OTHER
Collaborators: name: University of Klagenfurt
First posted: 2022-02-25
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single treatment group.
Primary purpose: DIAGNOSTIC

Brief 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.

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.

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.

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.

Eligibility criteria: Inclusion Criteria:

* Trigeminal neuralgia
* Postherpetic neuralgia
* Glossopharyngeal neuralgia
* Atypical facial pain

Exclusion Criteria:

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

Primary outcomes:
measure: Distribution of the injected fluid in the area of the superior cervical ganglion
timeFrame: immediately after the intervention
Secondary outcomes:
measure: Quality of life questionnaire
timeFrame: Before first and after last GLOA. After 1 and 3 month (follow up)
measure: Pain assessed by NRS
timeFrame: baseline, immediately after intervention, After 1 and 3 month (follow up)
measure: Patient satisfaction assessed by satisfaction questionaire
timeFrame: Before first and after last GLOA. After 1 and 3 month (follow up)
measure: Sleep quality assessed by sleep quality questionnaire
timeFrame: Before first and after last GLOA. After 1 and 3 month (follow up)
measure: Efficacy prediction based on MRI verified fluid spread
timeFrame: immediately after the intervention
Other outcomes:
Locations:
city: Klagenfurt
country: Austria
facility: Klinikum Klagenfurt am Wörthersee
Study officials:
affiliation: Klinikum Klagenfurt am Wörthersee
name: Rudolf Likar, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.