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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000027246
Receipt No. R000031212
Scientific Title Ultrasound image of expansion of the epidural space in pediatric epidural analgesia
Date of disclosure of the study information 2017/05/15
Last modified on 2017/05/04

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Basic information
Public title Ultrasound image of expansion of the epidural space in pediatric epidural analgesia
Acronym Uitrasound image of pediatric epidural space
Scientific Title Ultrasound image of expansion of the epidural space in pediatric epidural analgesia
Scientific Title:Acronym Uitrasound image of pediatric epidural space
Region
Japan

Condition
Condition Patients recieved epidural analgesia during surgery
Classification by specialty
Pediatrics Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Annalysis of relationship between patient's demographics and the expansion of epidural space
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The relationship between patient's demographics and the expansion of epidural space
Key secondary outcomes Success rate of clear observation of ultrasound image of epidural space

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment Central registration

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 Recording ultrasound image during epidural drug infusion
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
0 years-old <=
Age-upper limit
12 years-old >=
Gender Male and Female
Key inclusion criteria Pediatric patients recieved epidural analgesia during surgery
Key exclusion criteria Coagulation dysorder
Vertebral Deformity
Congenital heart disease
Allegy of local anesthetics
Preoperative neural symptom of extrimity
Unstable respiratry condition or hemodynamics
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiki Nakajima
Organization Hamamatsu University School of Medicine
Division name Anesthesiology
Zip code
Address 1-20-1 Handayama, Higashiku, Hamamatsu
TEL 053-435-2286
Email nakayos@hama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masahiro Yagihara
Organization Hamamatsu University School of Medicine
Division name Anesthesiology
Zip code
Address 1-20-1 Handayama, Higashiku, Hamamatsu
TEL 053-435-2286
Homepage URL
Email yagi@rj8.so-net.ne.jp

Sponsor
Institute Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization Hamamatsu University School of Medicine Department of Anesthesiology
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
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
2017 Year 05 Month 15 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
2017 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 05 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 05 Month 04 Day
Last modified on
2017 Year 05 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031212

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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