UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038512 |
|---|---|
| Receipt number | R000043882 |
| Scientific Title | A prospective comparative study of the efficacy and risk of landmark and ultrasound-guided methods in stellate ganglion block |
| Date of disclosure of the study information | 2019/11/08 |
| Last modified on | 2025/11/12 15:12:49 |
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Basic information
Public title
A prospective comparative study of the efficacy and risk of landmark and ultrasound-guided methods in stellate ganglion block
Acronym
A prospective comparative study of the efficacy and risk of landmark and ultrasound-guided methods in stellate ganglion block
Scientific Title
A prospective comparative study of the efficacy and risk of landmark and ultrasound-guided methods in stellate ganglion block
Scientific Title:Acronym
A prospective comparative study of the efficacy and risk of landmark and ultrasound-guided methods in stellate ganglion block
Region
| Japan |
Condition
Condition
1)Facial nerve palsy
2)Trigeminal nerve palsy
Classification by specialty
| Anesthesiology | Oral surgery | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose is to evaluate the difference in effect and risk between the landmark method and the ultrasound guided method.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Skin temperature distribution
Key secondary outcomes
1)Horner's symdrome
2)Presence or absence of miosis
3)Blood vessels around the 6th cervical vertebra
4)complications
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Landmark method SGB
Interventions/Control_2
Ultrasound guided SGB
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
trigeminal nerve palsy
Key exclusion criteria
1)Patient did not obtain consent
2)facial paralysis
3)Antithrombotic drug user
4)Patient with lidocaine allergy
5)Other patients who are considered inappropriate for inclusion in this study
Target sample size
27
Research contact person
Name of lead principal investigator
| 1st name | Madoka |
| Middle name | |
| Last name | Nagaura |
Organization
School of life dentistry at Tokyo, Nippon dental university
Division name
Department of oral and maxillofacial radiology
Zip code
102-8159
Address
1-9-20 Fujimi, Chiyoda-ku, Tokyo
TEL
03-3261-6516
madoka-a@tky.ndu.ac.jp
Public contact
Name of contact person
| 1st name | Madoka |
| Middle name | |
| Last name | Nagaura |
Organization
School of life dentistry at Tokyo, Nippon dental university
Division name
Department of oral and maxillofacial radiology
Zip code
102-8159
Address
1-9-20 Fujimi, Chiyoda-ku, Tokyo
TEL
03-3261-6516
Homepage URL
madoka-a@tky.ndu.ac.jp
Sponsor or person
Institute
School of life dentistry at Tokyo, Nippon dental university
Institute
Department
Personal name
Funding Source
Organization
Grants-in-aid for scientific research
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
School of life dentistry at Tokyo, Nippon dental university
Address
1-9-20 Fujimi, Chiyoda-ku, Tokyo
Tel
03-3261-6516
ndu-rinri@tky.ndu.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 11 | Month | 08 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000043882
Publication of results
Unpublished
Result
URL related to results and publications
Paper submission in progress
Number of participants that the trial has enrolled
27
Results
Skin temperature in the ear region showed no significant difference between LM-SGB and US-SGB, though US-SGB tended to be higher. In the nasal region, a significant difference appeared at 20 and 30 min after SGB, with higher values in US-SGB. In the cheek region, US-SGB showed significantly higher values at all time points. Ptosis and miosis showed no significant difference between techniques.
Results date posted
| 2025 | Year | 11 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients who underwent oral surgery at university hospitals and affiliated hospitals and subsequently developed trigeminal nerve disorders
Participant flow
There were 29 patients who provided consent for this study, but 2 dropped out during the process. The reason for this was that the hospital had imposed restrictions due to a COVID-19 outbreak at the time, and the patients' schedules did not align with the study dates.
Adverse events
Hoarseness was observed in 4 patients (LM-SGB: 2, US-SGB: 2), dysphagia in 13 patients (LM-SGB: 8, US-SGB: 5), and arm weakness in 4 patients (LM-SGB: 3, US-SGB: 1). All cases resolved spontaneously. No serious adverse events were observed.
Outcome measures
1. Change in skin temperature
2. Degree of ptosis
3. Degree of miosis
4. Presence of complications
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 09 | Month | 25 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 25 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 08 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 11 | Month | 07 | Day |
Last modified on
| 2025 | Year | 11 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043882
