UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022768 |
|---|---|
| Receipt number | R000026236 |
| Scientific Title | The Observation of catheterization in an Ultrasound-guided Thoracic Paravertebral Block Using Thoracoscopy |
| Date of disclosure of the study information | 2016/06/16 |
| Last modified on | 2018/12/11 09:40:43 |
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Basic information
Public title
The Observation of catheterization in an Ultrasound-guided Thoracic Paravertebral Block Using Thoracoscopy
Acronym
The Observation of catheterization in a Thoracic Paravertebral Block Using Thoracoscopy
Scientific Title
The Observation of catheterization in an Ultrasound-guided Thoracic Paravertebral Block Using Thoracoscopy
Scientific Title:Acronym
The Observation of catheterization in a Thoracic Paravertebral Block Using Thoracoscopy
Region
| Japan |
Condition
Condition
video-assisted thoracic surgery
Classification by specialty
| Chest surgery | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We observe how a paravertebral catheter is advanced into a thoracic paravertebral space in real time by using a thoracoscopy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We evaluate whether a paravertebral catheter can be advanced to the craniocaudal direction beyond the ribs?
Key secondary outcomes
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
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Ultrasound-guided paravertebral block by using thoracoscopy
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
Video Assisted Thoracic Surgery
Key exclusion criteria
Emergency surgery
Thoracotomy
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kimitoshi Nishiwaki |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Anesthesiology
Zip code
Address
65 Tsuruna-cho, Showa-ku, Nagoya, 466-8550 Japan
TEL
052-744-2340
nishi@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tasuku Fujii |
Organization
Nagoya University Hospital
Division name
Department of Anesthesiology
Zip code
Address
65 Tsuruna-cho, Showa-ku, Nagoya, 466-8550 Japan
TEL
052-744-2340
Homepage URL
plus9@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School
Institute
Department
Personal name
Funding Source
Organization
Nagoya University Graduate School
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Tosei General Hospital
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
| 2016 | Year | 06 | Month | 16 | 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
| 2015 | Year | 12 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 06 | Month | 16 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 06 | Month | 16 | Day |
Last modified on
| 2018 | Year | 12 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026236
