UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037673 |
|---|---|
| Receipt number | R000042964 |
| Scientific Title | Retrospective Analysis of Adverse Events of Continuous Interscalene Block Administered Using the Catheter-Over-Needle Method. |
| Date of disclosure of the study information | 2019/08/13 |
| Last modified on | 2019/08/13 12:21:49 |
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Basic information
Public title
Retrospective Analysis of Adverse Events of Continuous Interscalene Block Administered Using the Catheter-Over-Needle Method.
Acronym
Retrospective Analysis of Adverse Events of Continuous Interscalene Block Administered Using the Catheter-Over-Needle Method.
Scientific Title
Retrospective Analysis of Adverse Events of Continuous Interscalene Block Administered Using the Catheter-Over-Needle Method.
Scientific Title:Acronym
Retrospective Analysis of Adverse Events of Continuous Interscalene Block Administered Using the Catheter-Over-Needle Method.
Region
| Japan |
Condition
Condition
Interscalen block with catheter over needle
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We analyzed cases in which continuous interscalene block was administered using the catheter-over-needle method to determine when and what adverse events occurred.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence of the adverse event during continuous interscalen block with catheter over needle method
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
continuous interscalane block administered by anesthesiologists
Key exclusion criteria
continuous interscalane block administered by orthopedists
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kenichi |
| Middle name | |
| Last name | Takechi |
Organization
Matsuyama Red Cross Hospital
Division name
anesthesiology
Zip code
7908524
Address
1 Bunkyochou, Matsuyama City, Ehime Japan
TEL
0899241111
ntakechi@me.com
Public contact
Name of contact person
| 1st name | Kenichi |
| Middle name | |
| Last name | Takechi |
Organization
Matsuyama Red Cross Hospital
Division name
anesthesiology
Zip code
7908524
Address
1 Bunkyochou, Matsuyama City, Ehime Japan
TEL
0899241111
Homepage URL
ntakechi@me.com
Sponsor or person
Institute
Matsuyama Red Cross Hospital
Institute
Department
Personal name
Funding Source
Organization
Matsuyama Red Cross Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ehime Prefectural Imabari Hospital
Address
4-5-5 Ishiichou, Imabari City, Ehime, Japan
Tel
0898327111
ntakechi@me.com
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
| 2019 | Year | 08 | Month | 13 | 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
122
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 | 11 | Month | 30 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 30 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 30 | Day |
Last follow-up date
| 2019 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective Analysis
Management information
Registered date
| 2019 | Year | 08 | Month | 13 | Day |
Last modified on
| 2019 | Year | 08 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042964
