Ganglionic Local Opioid Analgesia at the Ganglion Cervicale Superius (GLOA-MRT)

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.

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.

Study Overview

• Status: Completed
• Conditions: Glossopharyngeal Neuralgia; Trigeminal Neuralgia, Idiopathic; Postherpetic; Neuralgia, Trigeminal (Etiology); Atypical Facial Pain
• Intervention / Treatment: Procedure: MRI after ganglionic local opioid analgesia (GLOA)

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.

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rudolf Likar, Prof.; Phone Number: 00434635380; Email: rudolf.likar@kabeg.at
• Study Contact Backup: Name: Stefan Neuwersch-Sommeregger, MD; Phone Number: 00434635380; Email: stefan.neuwersch@kabeg.at

Study Locations

• Austria
  • Klagenfurt, Austria, 9020
    • Klinikum Klagenfurt am Wörthersee

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

Collaborators and Investigators

• Sponsor: Klinikum Klagenfurt am Wörthersee
• Collaborators: University of Klagenfurt
• Investigators: Principal Investigator: Rudolf Likar, Prof., Klinikum Klagenfurt am Wörthersee

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2023
• Primary Completion (Actual): August 31, 2023
• Study Completion (Actual): October 1, 2023

Study Registration Dates

• First Submitted: January 31, 2022
• First Submitted That Met QC Criteria: February 24, 2022
• First Posted (Actual): February 25, 2022

Study Record Updates

• Last Update Posted (Actual): October 3, 2023
• Last Update Submitted That Met QC Criteria: October 1, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: GLOA, MRI,
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Stomatognathic Diseases; Mouth Diseases; Peripheral Nervous System Diseases; Cranial Nerve Diseases; Facial Nerve Diseases; Trigeminal Nerve Diseases; Facial Neuralgia; Neuralgia; Facial Pain; Trigeminal Neuralgia; Glossopharyngeal Nerve Diseases; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Narcotics; Analgesics, Opioid
• Other Study ID Numbers: 0815-2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No