Ganglionic Local Opioid Analgesia at the Ganglion Cervicale Superius (GLOA-MRT)
Primary Purpose
Trigeminal Neuralgia, Idiopathic, Postherpetic; Neuralgia, Trigeminal (Etiology), Glossopharyngeal Neuralgia
Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
MRI after ganglionic local opioid analgesia (GLOA)
Sponsored by
About this trial
This is an interventional diagnostic trial for Trigeminal Neuralgia, Idiopathic focused on measuring GLOA, 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
Sites / Locations
- Klinikum Klagenfurt am Wörthersee
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Intervention
Arm Description
MRI after Ganglionic Local Opioid Analgesia at the Ganglion Cervicale Superius;
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Quality of life questionnaire
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/)
Pain assessed by NRS
Present pain intensity on a 0-10 Numerical Rating Scale (NRS) with 0 corresponding to "no pain" and 10 to "the worst pain imaginable
Patient satisfaction assessed by satisfaction questionaire
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.
Sleep quality assessed by sleep quality questionnaire
To record the sleep quality the questionnaire on sleep quality is carried out (PSQI)
Efficacy prediction based on MRI verified fluid spread
Efficacy prediction based on the MRI verified fluid spread in millimeter in the area of the superior cervical ganglion
Full Information
NCT ID
NCT05257655
First Posted
January 31, 2022
Last Updated
October 1, 2023
Sponsor
Klinikum Klagenfurt am Wörthersee
Collaborators
University of Klagenfurt
1. Study Identification
Unique Protocol Identification Number
NCT05257655
Brief Title
Ganglionic Local Opioid Analgesia at the Ganglion Cervicale Superius
Acronym
GLOA-MRT
Official Title
MRI Observation After Ganglionic Local Opioid Analgesia at the Ganglion Cervicale Superius
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
January 9, 2023 (Actual)
Primary Completion Date
August 31, 2023 (Actual)
Study Completion Date
October 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Klinikum Klagenfurt am Wörthersee
Collaborators
University of Klagenfurt
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trigeminal Neuralgia, Idiopathic, Postherpetic; Neuralgia, Trigeminal (Etiology), Glossopharyngeal Neuralgia, Atypical Facial Pain
Keywords
GLOA, MRI,
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single treatment group.
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Other
Arm Description
MRI after Ganglionic Local Opioid Analgesia at the Ganglion Cervicale Superius;
Intervention Type
Procedure
Intervention Name(s)
MRI after ganglionic local opioid analgesia (GLOA)
Other Intervention Name(s)
MRI
Intervention Description
MRI after Ganglionic Local Opioid Analgesia at the Ganglion Cervicale Superius
Primary Outcome Measure Information:
Title
Distribution of the injected fluid in the area of the superior cervical ganglion
Description
MRI verified distribution of the injected fluid in the area of the superior cervical ganglion
Time Frame
immediately after the intervention
Secondary Outcome Measure Information:
Title
Quality of life questionnaire
Description
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/)
Time Frame
Before first and after last GLOA. After 1 and 3 month (follow up)
Title
Pain assessed by NRS
Description
Present pain intensity on a 0-10 Numerical Rating Scale (NRS) with 0 corresponding to "no pain" and 10 to "the worst pain imaginable
Time Frame
baseline, immediately after intervention, After 1 and 3 month (follow up)
Title
Patient satisfaction assessed by satisfaction questionaire
Description
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.
Time Frame
Before first and after last GLOA. After 1 and 3 month (follow up)
Title
Sleep quality assessed by sleep quality questionnaire
Description
To record the sleep quality the questionnaire on sleep quality is carried out (PSQI)
Time Frame
Before first and after last GLOA. After 1 and 3 month (follow up)
Title
Efficacy prediction based on MRI verified fluid spread
Description
Efficacy prediction based on the MRI verified fluid spread in millimeter in the area of the superior cervical ganglion
Time Frame
immediately after the intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rudolf Likar, Prof.
Organizational Affiliation
Klinikum Klagenfurt am Wörthersee
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinikum Klagenfurt am Wörthersee
City
Klagenfurt
ZIP/Postal Code
9020
Country
Austria
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
16142462
Citation
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.
Results Reference
background
PubMed Identifier
9167469
Citation
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.
Results Reference
background
Learn more about this trial
Ganglionic Local Opioid Analgesia at the Ganglion Cervicale Superius
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