Ganglionic Local Opioid Analgesia at the Ganglion Cervicale Superius

NCT05257655 | Completed

• 1 other identifier: 0815-2021
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

GLOA, MRI,

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Quality of life questionnaire

  Before first and after last GLOA. After 1 and 3 month (follow up)

• Pain assessed by NRS

  baseline, immediately after intervention, After 1 and 3 month (follow up)

• Patient satisfaction assessed by satisfaction questionaire

  Before first and after last GLOA. After 1 and 3 month (follow up)

• Sleep quality assessed by sleep quality questionnaire

  Before first and after last GLOA. After 1 and 3 month (follow up)

• Efficacy prediction based on MRI verified fluid spread

  immediately after the intervention

Study Arms (1)

Intervention

OTHER

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

Procedure: MRI after ganglionic local opioid analgesia (GLOA)

Interventions

MRI after ganglionic local opioid analgesia (GLOA) PROCEDURE

MRI after Ganglionic Local Opioid Analgesia at the Ganglion Cervicale Superius

Also known as: MRI

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Trigeminal neuralgia
• Postherpetic neuralgia
• Glossopharyngeal neuralgia
• Atypical facial pain

You may not qualify if:

• psychosis
• language barrier
• Pregnant and breastfeeding women
• Seizure disorders (epilepsy)
• Increased risk of bleeding

Sponsors & Collaborators

• Klinikum Klagenfurt am Wörthersee: lead
• University of Klagenfurt: collaborator

Study Sites (1)

Klinikum Klagenfurt am Wörthersee

Klagenfurt, 9020, Austria

Location

Related Publications (3)

• 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.

  PMID: 16142462 BACKGROUND

• 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.

  PMID: 9167469 BACKGROUND

• 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.

  PMID: 38662320 DERIVED

MeSH Terms

Conditions

Trigeminal Neuralgia; Neuralgia; Glossopharyngeal Nerve Diseases

Condition Hierarchy (Ancestors)

Trigeminal Nerve Diseases; Facial Neuralgia; Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Rudolf Likar, Prof.

  Klinikum Klagenfurt am Wörthersee

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prim. Univ. Prof. Dr. MSc.

Model Details: Single treatment group.

Study Record Dates

• First Submitted: January 31, 2022
• First Posted: February 25, 2022
• Study Start: January 9, 2023
• Primary Completion: August 31, 2023
• Study Completion: October 1, 2023
• Last Updated: October 3, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)