UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006997 |
|---|---|
| Receipt number | R000008255 |
| Scientific Title | The change of skin perfusion pressure after epidural block |
| Date of disclosure of the study information | 2012/01/31 |
| Last modified on | 2012/06/09 13:12:25 |
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Basic information
Public title
The change of skin perfusion pressure after epidural block
Acronym
The change of skin perfusion pressure after epidural block
Scientific Title
The change of skin perfusion pressure after epidural block
Scientific Title:Acronym
The change of skin perfusion pressure after epidural block
Region
| Japan |
Condition
Condition
Patients who have pain in the back and lower limbs
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we study whether measurements of skin perfusion pressure can assess the effect of epidural block.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Skin perfusion pressure: before epidural block, 30minutes after epidural block and 60 minutes after epidural block.2) Pain: Visual Analog Scale before epidural block and 60minutes after epidural block.
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Outpatients scheduled to undergo epidural block for the treatment of low back pain or pain of lower limbs
Key exclusion criteria
Patients were diagnosed with a clinical condition in which performing epidural block was contraindicated.
And patients who have peripheral vascular disease, disorder of sympathetic nervous system, history of convulsion, pregnant woman and abuse of drugs.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ichiro Hase |
Organization
Osaka city university graduate school of medicine
Division name
anesthesiology
Zip code
Address
Asahimachi 1-5-7 Abenoku Osaka 545-8586, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Osaka city university graduate school of medicine
Division name
anesthesiology
Zip code
Address
TEL
06-6645-2121(2186)
Homepage URL
Sponsor or person
Institute
Osaka city university graduate school of medicine
Institute
Department
Personal name
Funding Source
Organization
The Osaka Medical Research Foundation for Incurable Disease
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2012 | Year | 01 | Month | 31 | 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
| 2011 | Year | 12 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 02 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This prospective study is about the change of skin perfusion pressure after neural blockade
Management information
Registered date
| 2011 | Year | 12 | Month | 31 | Day |
Last modified on
| 2012 | Year | 06 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008255
