UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033046 |
|---|---|
| Receipt number | R000037680 |
| Scientific Title | Incidence investigation for phrenic nerve paralysis after erector spinae plane block-retrospective study- |
| Date of disclosure of the study information | 2018/06/19 |
| Last modified on | 2018/12/19 09:41:20 |
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Basic information
Public title
Incidence investigation for phrenic nerve paralysis after erector spinae plane block-retrospective study-
Acronym
Incidence investigation for phrenic nerve paralysis after erector spinae plane block
Scientific Title
Incidence investigation for phrenic nerve paralysis after erector spinae plane block-retrospective study-
Scientific Title:Acronym
Incidence investigation for phrenic nerve paralysis after erector spinae plane block
Region
| Japan |
Condition
Condition
Cases performed erector spinae plane block at the upper thoracic level
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Safety
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of phrenic nerve paralysis
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
cases performed erector spinae plane block at the upper thoracic level
Key exclusion criteria
cases performed the surgery, related to phrenic nerve
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hironobu Ueshima |
Organization
Showa university hospital
Division name
Anesthesiology
Zip code
Address
1-5-8, hatanodai shinagawa-ku. tokyo
TEL
03-3784-8575
ueshimhi@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hironobu Ueshima |
Organization
Showa university hospital
Division name
Anesthesiology
Zip code
Address
1-5-8, hatanodai, shinagawa-ku, tokyo
TEL
03-3784-8575
Homepage URL
ueshimhi@med.showa-u.ac.jp
Sponsor or person
Institute
Showa university hospital
Institute
Department
Personal name
Funding Source
Organization
Showa 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
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
| 2018 | Year | 06 | Month | 19 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2018 | Year | 06 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 06 | Month | 19 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Cases between April 2016 and March 2018.
Management information
Registered date
| 2018 | Year | 06 | Month | 19 | Day |
Last modified on
| 2018 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037680
