UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018073
Receipt number R000020920
Scientific Title comparison of traditional thoracic paravertebral block and laminal paravertebral block
Date of disclosure of the study information 2015/06/24
Last modified on 2017/12/25 15:23:30

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Basic information

Public title

comparison of traditional thoracic paravertebral block and laminal paravertebral block

Acronym

comparison of traditional thoracic paravertebral block and laminal paravertebral block

Scientific Title

comparison of traditional thoracic paravertebral block and laminal paravertebral block

Scientific Title:Acronym

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

1st name
Middle name
Last name kazuo ando

Organization

Aichi Medical University

Division name

department of anesthesia

Zip code


Address

1-1 Yazakokarimata, Nagakute,Aichi

TEL

0561-62-3311

Email

ando_kazuo0210@hotmail.com


Public contact

Name of contact person

1st name
Middle name
Last name kazuo ando

Organization

Aichi Medical University

Division name

department of anesthesia

Zip code


Address

1-1 Yazakokarimata, Nagakute,Aichi

TEL

0561-62-3311

Homepage URL


Email

ando_kazuo0210@hotmail.com


Sponsor or person

Institute

Aichi Medical University

Institute

Department

Personal name



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)



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



Other administrative information

Date of disclosure of the study information

2015 Year 06 Month 24 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

Terminated

Date of protocol fixation

2015 Year 06 Month 25 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020920


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name