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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000040404
Receipt No. R000046106
Scientific Title A comparison of tissue oxygenation between stellate ganglion block and xenon stellate ganglion irradiation.
Date of disclosure of the study information 2020/05/15
Last modified on 2020/05/14

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Basic information
Public title A comparison of tissue oxygenation between stellate ganglion block and xenon stellate ganglion irradiation.
Acronym A comparison of tissue oxygenation between stellate ganglion block and xenon stellate ganglion irradiation.
Scientific Title A comparison of tissue oxygenation between stellate ganglion block and xenon stellate ganglion irradiation.
Scientific Title:Acronym A comparison of tissue oxygenation between stellate ganglion block and xenon stellate ganglion irradiation.
Region
Japan

Condition
Condition Post-operative Trigeminal Sensory Neuropathy
Classification by specialty
Oral surgery Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In order to investigate the variation of tissue oxygenation when conducting stellate ganglion block and xenon stellate ganglion irradiation.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Tissue oxygenation index (TOI),
Normalized tissue hemoglobin index (nTHI),
Oxygenated hemoglobin concentration (O2Hb),
Deoxygenated hemoglobin concentration (HHb),
Total hemoglobin concentration (cHb)
Key secondary outcomes Semmes Weinstein monofilament test

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine Device,equipment
Interventions/Control_1 Conducting SGB by 1% lidocaine hydrochloride
Interventions/Control_2 Conducting SGB by 1% mepivacaine hydrochloride
Interventions/Control_3 Conducting xenon stellate ganglion irradiation
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
17 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria Post-operative trigeminal sensory neuropathy which needed SGB for treatment
Key exclusion criteria coagulation disorder,
antithrombotic therapy,
neck tumor or infections,
pathological conditions predicting hematogenous disorder in facial arteriovenous,
unexplained causes of injury,
ASA-physical status > 3
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Hidetaka
Middle name
Last name Kuroda
Organization Kanagawa Dental University
Division name Department of Critical Care Medicine and Dentistry
Zip code 238-0004
Address 1-23 Ogawa-cho Yokosuka-shi Kanagawa, Japan
TEL 0468228896
Email kuroda@kdu.ac.jp

Public contact
Name of contact person
1st name HIDETAKA
Middle name
Last name KURODA
Organization Kanagawa Dental University
Division name Department of Critical Care Medicine and Dentistry
Zip code 238-0004
Address 1-23 Ogawa-cho Yokosuka-shi Kanagawa, Japan
TEL 0468228896
Homepage URL
Email kuroda@kdu.ac.jp

Sponsor
Institute Kanagawa Dental University
Institute
Department

Funding Source
Organization Kanagawa Dental University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization the Ethics Committee of Kanagawa Dental University
Address 1-23 Ogawa-cho Yokosuka-shi Kanagawa, Japan
Tel 0468228896
Email murakami@kdu.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 神奈川歯科大学附属病院

Other administrative information
Date of disclosure of the study information
2020 Year 05 Month 15 Day

Related information
URL releasing protocol http://www.labs.kdu.ac.jp/gakkai/
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled 13
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 No longer recruiting
Date of protocol fixation
2019 Year 08 Month 27 Day
Date of IRB
2019 Year 08 Month 27 Day
Anticipated trial start date
2019 Year 09 Month 01 Day
Last follow-up date
2020 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 05 Month 14 Day
Last modified on
2020 Year 05 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046106

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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