Trials / Completed
CompletedNCT05257655
Ganglionic Local Opioid Analgesia at the Ganglion Cervicale Superius
MRI Observation After Ganglionic Local Opioid Analgesia at the Ganglion Cervicale Superius
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 3 (actual)
- Sponsor
- Klinikum Klagenfurt am Wörthersee · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Trigeminal Neuralgia, Idiopathic
- Postherpetic; Neuralgia, Trigeminal (Etiology)
- Glossopharyngeal Neuralgia
- Atypical Facial Pain
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | MRI after ganglionic local opioid analgesia (GLOA) | MRI after Ganglionic Local Opioid Analgesia at the Ganglion Cervicale Superius |
Timeline
- Start date
- 2023-01-09
- Primary completion
- 2023-08-31
- Completion
- 2023-10-01
- First posted
- 2022-02-25
- Last updated
- 2023-10-03
Locations
1 site across 1 country: Austria
Source: ClinicalTrials.gov record NCT05257655. Inclusion in this directory is not an endorsement.