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

Klinikum Klagenfurt am Wörthersee

Status: Completed

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

Treatments: Procedure: MRI after ganglionic local opioid analgesia (GLOA)

Study type: Interventional

Funder types: Other

Identifiers

NCT05257655

0815-2021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

Intervention

Other group

Description:

MRI after Ganglionic Local Opioid Analgesia at the Ganglion Cervicale Superius;

Treatment:

Procedure: MRI after ganglionic local opioid analgesia (GLOA)