NCT05257655|Completed
Ganglionic Local Opioid Analgesia at the Ganglion Cervicale Superius
GLOA-MRT
MRI Observation After Ganglionic Local Opioid Analgesia at the Ganglion Cervicale Superius
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GLOA-MRT
MRI Observation After Ganglionic Local Opioid Analgesia at the Ganglion Cervicale Superius
Sponsor study identifier
interventional
3
1 country
1
Study Start
January 9, 2023
Actual (reported)Primary Completion
August 31, 2023
Actual (reported)Study Completion
October 1, 2023
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 1, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 31, 2022
Actual (reported)February 25, 2022
Actual (reported)January 9, 2023
Actual (reported)August 31, 2023
Actual (reported)October 1, 2023
Actual (reported)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
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)
MRI after Ganglionic Local Opioid Analgesia at the Ganglion Cervicale Superius;
MRI after Ganglionic Local Opioid Analgesia at the Ganglion Cervicale Superius
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Klinikum Klagenfurt am Wörthersee
Klagenfurt, 9020, Austria
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.
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.
Rudolf Likar, Prof.
Klinikum Klagenfurt am Wörthersee
3 participants (actual enrollment reported by the registry).
First Submitted
January 31, 2022
First Posted
February 25, 2022
Study Start
January 9, 2023
Actual (reported)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
Contact the study team to confirm eligibility.
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.
Primary Completion
August 31, 2023
Actual (reported)Study Completion
October 1, 2023
Actual (reported)Last Updated
October 3, 2023
Record last verified: 2023-10
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Source: ClinicalTrials.gov.
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