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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000015988
Receipt No. R000018490
Scientific Title n analysis of paravertebral catheters placement and spread compared ultrasound-guided paravertebral block transverse plane approach and sagittal plane approach.
Date of disclosure of the study information 2015/02/01
Last modified on 2016/06/18

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Basic information
Public title n analysis of paravertebral catheters placement and spread compared ultrasound-guided paravertebral block transverse plane approach and sagittal plane approach.
Acronym n analysis of paravertebral catheters placement and spread compared ultrasound-guided paravertebral block transverse plane approach and sagittal plane approach.
Scientific Title n analysis of paravertebral catheters placement and spread compared ultrasound-guided paravertebral block transverse plane approach and sagittal plane approach.
Scientific Title:Acronym n analysis of paravertebral catheters placement and spread compared ultrasound-guided paravertebral block transverse plane approach and sagittal plane approach.
Region
Japan

Condition
Condition Thoracic surgery (Unilateral thoracotomy and video-assisted thoracoscopic surgery)
Classification by specialty
Chest surgery Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Ultrasound-guided paravertebral block, there are two techniques of transverse plane approach and sagittal plane approach. Consider tip position and spread of solution of the paravertebral catheters by approach of these ultrasound-guided paravertebral block approaches, to evaluate and its effectiveness approach more effective paravertebral block.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Paravertebral catheters placement
Key secondary outcomes Spread of drug solution
VAS after surgery 24 hours
Number of times of use iv-PCA
Frequency of use iv-PCA

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is 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 Transverse plane approach of ultrasound guided paravertebral block
Interventions/Control_2 Saggital plane approach of ultrasound guided paravertebral 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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patient of lung cancer
Scheduled thoracotomy or thoracoscopic surgery.
ASA classification(class1, class2)
Document those obtained consent
Key exclusion criteria Emergency surgery.
ASA classification class3 or more.
Patients and including a history, convulsions, there is epilepsy and its quality.
Patients with a history and existing bronchial asthma.
Patients with a history of some of-iodine or contrast agent allergy.
Patients, a thyroid disease.
Clotting disorder Some of the (less than 100,000 platelets/10-3ml, PT-INR is 2 or more or APTT% is less than 70%).
Renal dysfunction (less than eGFR60).
Target sample size 60

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 Nagoya University Graduate School of Medicine
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
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

Other administrative information
Date of disclosure of the study information
2015 Year 02 Month 01 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
2014 Year 12 Month 08 Day
Date of IRB
Anticipated trial start date
2015 Year 07 Month 01 Day
Last follow-up date
2017 Year 03 Month 31 Day
Date of closure to data entry
2017 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 12 Month 18 Day
Last modified on
2016 Year 06 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018490

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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