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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000038512
Receipt No. 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 2019/11/07

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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 Suzuki
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
Email madoka-a@tky.ndu.ac.jp

Public contact
Name of contact person
1st name Madoka
Middle name
Last name Suzuki
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
Email madoka-a@tky.ndu.ac.jp

Sponsor
Institute School of life dentistry at Tokyo, Nippon dental university
Institute
Department

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
Email 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
2019 Year 11 Month 07 Day


Link to view the page
URL(English) https://upload.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


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