UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016472
Receipt number R000019135
Scientific Title An analysis of catheterization and solution spread in ultrasound-guided paravertebral block under thoracoscopy
Date of disclosure of the study information 2015/02/25
Last modified on 2018/12/11 09:31:39

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Basic information

Public title

An analysis of catheterization and solution spread in ultrasound-guided paravertebral block under thoracoscopy

Acronym

An analysis of catheterization and solution spread in ultrasound-guided paravertebral block under thoracoscopy

Scientific Title

An analysis of catheterization and solution spread in ultrasound-guided paravertebral block under thoracoscopy

Scientific Title:Acronym

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

1st name
Middle name
Last name Kimitoshi Nishiwaki

Organization

Nagoya University Graduate School of Medicine

Division name

Department of Anesthesiology

Zip code


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

1st name
Middle name
Last name Tasuku Fujii

Organization

Nagoya University Hospital

Division name

Department of Anesthesiology

Zip code


Address

65 Tsuruna-cho, Showa-ku, Nagoya, 466-8550 Japan

TEL

052-744-2340

Homepage URL


Email

plus9@med.nagoya-u.ac.jp


Sponsor or person

Institute

Nagoya University Graduate School of Medicine, Biomedical Regulation, Department of Anesthesiology

Institute

Department

Personal name



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)



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

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


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

Completed

Date of protocol fixation

2015 Year 01 Month 01 Day

Date of IRB


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


Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019135


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name