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Completed

NCT Number: NCT05257655

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.

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Key information

Conditions

Trigeminal Neuralgia, Idiopathic Atypical Facial Pain Cranial Nerve Diseases Facial Nerve Diseases Facial Neuralgia Glossopharyngeal Nerve Diseases Glossopharyngeal Neuralgia Mouth Diseases Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Postherpetic; Neuralgia, Trigeminal (Etiology) Signs and Symptoms Stomatognathic Diseases Trigeminal Nerve Diseases Trigeminal Neuralgia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Klinikum Klagenfurt am Wörthersee

Klagenfurt, 9020, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MRI after ganglionic local opioid analgesia (GLOA)

Procedure

MRI after Ganglionic Local Opioid Analgesia at the Ganglion Cervicale Superius

Other names: MRI

Primary outcomes

  1. Distribution of the injected fluid in the area of the superior cervical ganglion

    Time frame: immediately after the intervention

    MRI verified distribution of the injected fluid in the area of the superior cervical ganglion

Secondary outcomes

  1. Quality of life questionnaire

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

    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/)

  2. Pain assessed by NRS

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

    Present pain intensity on a 0-10 Numerical Rating Scale (NRS) with 0 corresponding to "no pain" and 10 to "the worst pain imaginable

  3. Patient satisfaction assessed by satisfaction questionaire

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

    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.

  4. Sleep quality assessed by sleep quality questionnaire

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

    To record the sleep quality the questionnaire on sleep quality is carried out (PSQI)

  5. Efficacy prediction based on MRI verified fluid spread

    Time frame: immediately after the intervention

    Efficacy prediction based on the MRI verified fluid spread in millimeter in the area of the superior cervical ganglion

Sponsors and collaborators

Lead sponsor

Klinikum Klagenfurt am Wörthersee

Other

Collaborators

  • University of Klagenfurt

Registry information

Official study title

MRI Observation After Ganglionic Local Opioid Analgesia at the Ganglion Cervicale Superius

Acronym: GLOA-MRT

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 25, 2022
Registry last updated
Oct 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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