Atypical Facial Pain, Glossopharyngeal Neuralgia, Postherpetic; Neuralgia, Trigeminal (Etiology), Trigeminal Neuralgia, Idiopathic
Conditions
Keywords
GLOA, MRI,
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.
Interventions
PROCEDUREMRI after ganglionic local opioid analgesia (GLOA)
MRI after Ganglionic Local Opioid Analgesia at the Ganglion Cervicale Superius
Sponsors
University of Klagenfurt
Klinikum Klagenfurt am Wörthersee
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Single treatment group.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Distribution of the injected fluid in the area of the superior cervical ganglion | immediately after the intervention | MRI verified distribution of the injected fluid in the area of the superior cervical ganglion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life questionnaire | Before first and after last GLOA. After 1 and 3 month (follow up) | 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/) |
| Pain assessed by NRS | baseline, immediately after intervention, After 1 and 3 month (follow up) | Present pain intensity on a 0-10 Numerical Rating Scale (NRS) with 0 corresponding to no pain and 10 to the worst pain imaginable |
| Patient satisfaction assessed by satisfaction questionaire | Before first and after last GLOA. After 1 and 3 month (follow up) | 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. |
| Sleep quality assessed by sleep quality questionnaire | Before first and after last GLOA. After 1 and 3 month (follow up) | To record the sleep quality the questionnaire on sleep quality is carried out (PSQI) |
| Efficacy prediction based on MRI verified fluid spread | immediately after the intervention | Efficacy prediction based on the MRI verified fluid spread in millimeter in the area of the superior cervical ganglion |
Countries
Austria
Outcome results
None listed