UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052837 |
|---|---|
| Receipt number | R000060298 |
| Scientific Title | Examination of the usefulness of laser speckle flowgraphy in determining the effectiveness of lumbar sympathetic ganglion block |
| Date of disclosure of the study information | 2023/11/18 |
| Last modified on | 2023/11/18 11:55:21 |
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Basic information
Public title
Examination of the usefulness of laser speckle flowgraphy in determining the effectiveness of lumbar sympathetic ganglion block
Acronym
Utility of laser speckle flowgraphy in lumbar sympathetic ganglion block
Scientific Title
Examination of the usefulness of laser speckle flowgraphy in determining the effectiveness of lumbar sympathetic ganglion block
Scientific Title:Acronym
Utility of laser speckle flowgraphy in lumbar sympathetic ganglion block
Region
| Japan |
Condition
Condition
Severe limb ischemia
Classification by specialty
| Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to investigate changes in plantar blood flow measurements before and after lumbar sympathetic ganglion block, and to evaluate the usefulness of LSFG-PET in determining the effectiveness of lumbar sympathetic ganglion block.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Plantar blood flow measurement values before and after lumbar sympathetic ganglion block measured by LSFG-PET
Key secondary outcomes
Changes in plantar temperature before and after lumbar sympathetic ganglion block
Changes in clinical symptoms such as pain
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
Patients undergoing lumbar sympathetic ganglion block at our facility
Key exclusion criteria
Patients who do not consent to testing
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Izumi |
| Middle name | |
| Last name | Sarto |
Organization
Asahikawa Medical University
Division name
Department of Anesthesiology and Critical Care Medicine
Zip code
078-8510
Address
Midorigaoka-higashi 2-1-1-1, Asahikawa, Hokkaido, Japan
TEL
0166-68-2583
izumihata323@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Izumi |
| Middle name | |
| Last name | Sato |
Organization
Asahikawa Medical University
Division name
Department of Anesthesiology and Critical Care Medicine
Zip code
078-8510
Address
Midorigaoka-higashi 2-1-1-1, Asahikawa, Hokkaido, Japan
TEL
0166-68-2583
Homepage URL
izumihata323@yahoo.co.jp
Sponsor or person
Institute
Asahikawa Medical University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Asahikawa Medical University Research Support Division Research Planning Section
Address
Higashi 2-1-1-1,Midorigaoka,Asahikawa
Tel
0166-68-2297
rs-kp.g@asahikawa-med.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
| 2023 | Year | 11 | Month | 18 | 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
Preinitiation
Date of protocol fixation
| 2018 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 11 | Month | 30 | Day |
Last follow-up date
| 2028 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
When performing a lumbar sympathetic ganglion block, blood flow measurements are measured using laser speckle flowgraphy (LSFG-PET) before and after the procedure to determine its effectiveness.
The results will be analyzed and compared with changes in lower limb skin temperature and clinical symptoms.
Management information
Registered date
| 2023 | Year | 11 | Month | 18 | Day |
Last modified on
| 2023 | Year | 11 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060298
