UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040404 |
|---|---|
| Receipt number | 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 | 2021/03/29 17:07:58 |
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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 6 mL of 1% lidocaine hydrochloride
Interventions/Control_2
Conducting SGB by 6 mL of 1% mepivacaine hydrochloride
Interventions/Control_3
Conducting 10 min. 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
20
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
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
kuroda@kdu.ac.jp
Sponsor or person
Institute
Kanagawa Dental University
Institute
Department
Personal name
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
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
Our results suggest that SGB using by each local anesthetic solution increased in tissue oxygenation sequentially following by the increase in tissue blood flow in the affected-side. In the SGB using by lidocaine hydrochloride, the slightly same response was observed in the healthy-side although that was slower dynamics than that in affected-side. Mepivacaine hydrochloride may cause venous congestion on the affected-side.
Results date posted
| 2021 | Year | 03 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
There were no adverse events.
Outcome measures
The primary outcome was the variation in tissue oxygenation between that at the end of the injection and each minute after the SGB.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2019 | Year | 08 | Month | 27 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 27 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 15 | 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
| 2020 | Year | 05 | Month | 14 | Day |
Last modified on
| 2021 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046106
| Research Plan | |
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| Registered date | File name |
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