UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027246 |
|---|---|
| Receipt number | 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 16:28:28 |
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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
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
yagi@rj8.so-net.ne.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031212
