UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The Observation of catheterization in an Ultrasound-guided Thoracic Paravertebral Block Using Thoracoscopy
Title of the study (Brief title)	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	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
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 12 Month 08 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026236