UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	n analysis of paravertebral catheters placement and spread compared ultrasound-guided paravertebral block transverse plane approach and sagittal plane approach.
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Kimitoshi Nishiwaki
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Anesthesiology
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	Tasuku Fujii
Organization	Nagoya University Hospital
Division name	Department of Anesthesiology
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 12 Month 08 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000018490