UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	comparison of traditional thoracic paravertebral block and laminal paravertebral block
Title of the study (Brief title)	comparison of traditional thoracic paravertebral block and laminal paravertebral block
Region	Japan

Condition
Condition	lung cancer
Classification by specialty	Chest surgery Anesthesiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	comparison of traditional paravertebral block and laminal paravertebral block, during lung cancer operation and post operative pain management
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	post operative pain
Key secondary outcomes	blood concentration of local analgesia heart rate variability analysis complication

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	traditional thoracic paravertebral block
Interventions/Control_2	laminal thoracic paraveertebral 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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	lung cancer patient who are scheduled to take video-assisted thoracic surgery
Key exclusion criteria	the patient who do not consent with this study the patient who has dementia to take pain scale the patient who has allergic to local analgesia the patient who has allergic to opioid the patient who judged other chief physicians to be inappropriate about the study concerned
Target sample size	100

Research contact person
Name of lead principal investigator	kazuo ando
Organization	Aichi Medical University
Division name	department of anesthesia
Address	1-1 Yazakokarimata, Nagakute,Aichi
TEL	0561-62-3311
Email	ando_kazuo0210@hotmail.com

Public contact
Name of contact person	kazuo ando
Organization	Aichi Medical University
Division name	department of anesthesia
Address	1-1 Yazakokarimata, Nagakute,Aichi
TEL	0561-62-3311
Homepage URL
Email	ando_kazuo0210@hotmail.com

Sponsor
Institute	Aichi Medical University
Institute
Department

Funding Source
Organization	department of anesthesia,Aichi Medical University
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

Other administrative information
Date of disclosure of the study information	2015 Year 06 Month 24 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 06 Month 25 Day
Anticipated trial start date	2015 Year 06 Month 25 Day
Last follow-up date
Date of closure to data entry
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	2015 Year 06 Month 24 Day
Last modified on	2017 Year 12 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020920