Ganglionic Local Opioid Analgesia at the Ganglion Cervicale Superius

Study Overview
=================
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.

Official Title
-----------------
MRI Observation After Ganglionic Local Opioid Analgesia at the Ganglion Cervicale Superius

Conditions
-----------------
Trigeminal Neuralgia, Idiopathic, Postherpetic; Neuralgia, Trigeminal (Etiology), Glossopharyngeal Neuralgia, Atypical Facial Pain

Intervention / Treatment
-----------------
* Procedure: MRI after ganglionic local opioid analgesia (GLOA)


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Single treatment group.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Intervention<br>MRI after Ganglionic Local Opioid Analgesia at the Ganglion Cervicale Superius; | Procedure: MRI after ganglionic local opioid analgesia (GLOA)<br>* MRI after Ganglionic Local Opioid Analgesia at the Ganglion Cervicale Superius<br>* Other names: MRI;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | immediately after the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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/) | Before first and after last GLOA. After 1 and 3 month (follow up) | 
| 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 | baseline, immediately after intervention, After 1 and 3 month (follow up) | 
| 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. | Before first and after last GLOA. After 1 and 3 month (follow up) | 
| Sleep quality assessed by sleep quality questionnaire | To record the sleep quality the questionnaire on sleep quality is carried out (PSQI) | Before first and after last GLOA. After 1 and 3 month (follow up) | 
| 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 | immediately after the intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GLOA, MRI,