UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038512 |
|---|---|
| Receipt number | R000043882 |
| Scientific Title | Randomized controlled trial on effect and risk of landmark method and ultrasonic guide method in stellate ganglion block |
| Date of disclosure of the study information | 2019/11/08 |
| Last modified on | 2022/05/11 10:02:16 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Randomized controlled trial on effect and risk of landmark method and ultrasonic guide method in stellate ganglion block
Acronym
Randomized controlled trial of landmark method and ultrasonic guide method for stellate ganglion block
Scientific Title
Randomized controlled trial on effect and risk of landmark method and ultrasonic guide method in stellate ganglion block
Scientific Title:Acronym
Randomized controlled trial of landmark method and ultrasonic guide method for 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
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are 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
1)facial nerve palsy
2)trigeminal nerve palsy
Key exclusion criteria
1)Patient did not obtain consent
2)Antithrombotic drug user
3)Patient with lidocaine allergy
4)Other patients who are considered inappropriate for inclusion in this study
Target sample size
30
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
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
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
| 2022 | Year | 05 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043882
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
