UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	An analysis of catheterization and solution spread in ultrasound-guided paravertebral block under thoracoscopy
Title of the study (Brief title)	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	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

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 01 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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