Ganglionic Local Opioid Analgesia at the Ganglion Cervicale Superius

Atypical Facial Pain Clinical Trial

— GLOA-MRT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05257655
• Other study ID #: 0815-2021
• Status: Completed
• Phase: N/A
• Start date: January 9, 2023
• Est. completion date: October 1, 2023

Study information

• Verified date: October 2023
• Source: Klinikum Klagenfurt am Wörthersee
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: October 1, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atypical Facial Pain
• Facial Pain
• Glossopharyngeal Neuralgia
• Neuralgia
• Trigeminal Neuralgia

Intervention

Procedure:
• MRI after ganglionic local opioid analgesia (GLOA)
MRI after Ganglionic Local Opioid Analgesia at the Ganglion Cervicale Superius

Locations

Country	Name	City	State
Austria	Klinikum Klagenfurt am Wörthersee	Klagenfurt

Sponsors (2)

Lead Sponsor	Collaborator
Klinikum Klagenfurt am Wörthersee	University of Klagenfurt

Country where clinical trial is conducted

Austria, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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