Ganglionic Local Opioid Analgesia at the Ganglion Cervicale Superius

NCT ID: NCT05257655

Last Updated: 2023-10-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-09
• Study Completion Date: 2023-10-01

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Intervention

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

Group Type: OTHER

MRI after ganglionic local opioid analgesia (GLOA)

Intervention Type: PROCEDURE

MRI after Ganglionic Local Opioid Analgesia at the Ganglion Cervicale Superius

Interventions

MRI after ganglionic local opioid analgesia (GLOA)

MRI after Ganglionic Local Opioid Analgesia at the Ganglion Cervicale Superius

Intervention Type: PROCEDURE

Other Intervention Names

MRI

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Klagenfurt

OTHER

Sponsor Role: collaborator

Klinikum Klagenfurt am Wörthersee

OTHER

Sponsor Role: lead

Responsible Party

Rudolf Likar

Prim. Univ. Prof. Dr. MSc.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rudolf Likar, Prof.

Role: PRINCIPAL_INVESTIGATOR

Klinikum Klagenfurt am Wörthersee

Locations

Klinikum Klagenfurt am Wörthersee

Klagenfurt, , Austria

Countries

Austria

References

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.

Reference Type: BACKGROUND

PMID: 16142462 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9167469 (View on PubMed)

Neuwersch-Sommeregger S, Kostenberger M, Sandner-Kiesling A, Furstner M, Igerc I, Trummer B, Wuntschek J, Pipam W, Stettner H, Likar R, Feigl G. Ganglionic Local Opioid Analgesia at the Superior Cervical Ganglion: MRI-Verified Solution Spread. Pain Ther. 2024 Jun;13(3):663-678. doi: 10.1007/s40122-024-00596-4. Epub 2024 Apr 25.

Reference Type: DERIVED

PMID: 38662320 (View on PubMed)

Other Identifiers

0815-2021

Identifier Type: -

Identifier Source: org_study_id