UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039959 |
|---|---|
| Receipt number | R000045468 |
| Scientific Title | Randomized comparative study of continuous errector spinae plane block and continuous paravertebral nerve block in pulmonary resection in children |
| Date of disclosure of the study information | 2020/12/31 |
| Last modified on | 2020/04/07 10:11:00 |
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Basic information
Public title
Randomized comparative study of continuous errector spinae plane block and continuous paravertebral nerve block in pulmonary resection in children
Acronym
ESP vs PVB in children
Scientific Title
Randomized comparative study of continuous errector spinae plane block and continuous paravertebral nerve block in pulmonary resection in children
Scientific Title:Acronym
ESP vs PVB in children
Region
| Japan |
Condition
Condition
lung disease
Classification by specialty
| Pediatrics | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Which is better for erectile spine block or paravertebral block for pulmonary resection in children?
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Use of adjuvant analgesics
Key secondary outcomes
FLACC score,PCA pump use history, number of use of adjuvant analgesics
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
errector planae block
Interventions/Control_2
paraertebral block
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
| 1 | years-old | <= |
Age-upper limit
| 15 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Pulmonary resection in children
Key exclusion criteria
Coagulation abnormalities
Liver dysfunction
Renal dysfunction
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | kimitoshi |
| Middle name | |
| Last name | nishiwaki |
Organization
nagoya university hospital
Division name
anesthesiology
Zip code
466-8560
Address
65, Tsurumai-cho, Showa-ku, Nagoya City, Aichi Prefecture
TEL
052-741-2111
nishi@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | nanako |
| Middle name | |
| Last name | taniguchi |
Organization
nagoya university hospital
Division name
anesthesiology
Zip code
466-8560
Address
65, Tsurumai-cho, Showa-ku, Nagoya City, Aichi Prefecture
TEL
052-741-2111
Homepage URL
http://www.nu-camcr.org/cms/
ninomiya-nanako@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya university hospital
Institute
Department
Personal name
Funding Source
Organization
nagoya university hospital
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
Nagoya university hospital
Address
65, Tsurumai-cho, Showa-ku, Nagoya City, Aichi Prefecture
Tel
052-741-2111
ninomiya-nanako@med.nagoya-u.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
| 2020 | Year | 12 | 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
Terminated
Date of protocol fixation
| 2020 | Year | 03 | Month | 27 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 03 | Month | 27 | Day |
Last modified on
| 2020 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045468
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
