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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016472
Receipt No. R000019135
Scientific Title An analysis of catheterization and solution spread in ultrasound-guided paravertebral block under thoracoscopy
Date of disclosure of the study information 2015/02/25
Last modified on 2018/12/11

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Basic information
Public title An analysis of catheterization and solution spread in ultrasound-guided paravertebral block under thoracoscopy
Acronym An analysis of catheterization and solution spread in ultrasound-guided paravertebral block under thoracoscopy
Scientific Title An analysis of catheterization and solution spread in ultrasound-guided paravertebral block under thoracoscopy
Scientific Title:Acronym An analysis of catheterization and solution spread in ultrasound-guided paravertebral block under thoracoscopy
Region
Japan

Condition
Condition video-assisted thoracic surgery
Classification by specialty
Chest surgery Anesthesiology Operative medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In direct observation by thoracoscopy, by performing an ultrasound-guided paravertebral block can be considered the paravertebral catheter placement and the spread of solution. Thereby, this research evaluates the approach of safer and more effective by ultrasound-gaidied paravertebral block.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Spread type of the solution
Key secondary outcomes Distance of the paravertebral catheter placement
Success rate of catheterization
(same intercostal level)
Check of paravertebral catheter by saline mixed air under ultrasound
Postoperative pain(VAS)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants 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 ultrasound-guided paravertebral block
(10ml injection group:saline)
(Later, local anesthetic 20ml injection from the catheter)
Interventions/Control_2 ultrasound-guided paravertebral block(30ml injection group:10mlsaline+20ml local anesthetic)
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
20 years-old <
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Elective video-assisted thoracic surgery patients (lung cancer, mediastinal tumor, pneumothorax, interstitial pneumonia, etc.)
20 years of age or older
ASA physical status classification(class1, class2)
Key exclusion criteria Minor
Impaired consciousness
There is not enough judgment ability
Emergency surgery
Class3 more ASA classification
hypersensitivity to ropivacaine or amide type local anesthetic
Hemodialysis
Advanced renal dysfunction(less than eGFR30)
Liver dysfunction (Child-Pugh classification more B)
Target sample size 34

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
Email 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
Email plus9@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Graduate School of Medicine, Biomedical Regulation, Department of Anesthesiology
Institute
Department

Funding Source
Organization none
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
Email

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 名古屋大学医学部附属病院
公立陶生病院

Other administrative information
Date of disclosure of the study information
2015 Year 02 Month 25 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 Completed
Date of protocol fixation
2015 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 06 Month 01 Day
Last follow-up date
2017 Year 03 Month 31 Day
Date of closure to data entry
2018 Year 03 Month 31 Day
Date trial data considered complete
2018 Year 03 Month 31 Day
Date analysis concluded
2018 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2015 Year 02 Month 08 Day
Last modified on
2018 Year 12 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019135

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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