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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000006997
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Osaka city university graduate school of medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008255

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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