UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015576
Receipt number R000017887
Scientific Title Evaluation of ultrasound-guided confirmation technique of paravertebral catheter tip location
Date of disclosure of the study information 2014/10/31
Last modified on 2018/03/31 10:21:57

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Basic information

Public title

Evaluation of ultrasound-guided confirmation technique of paravertebral catheter tip location

Acronym

Ultrasound-guided confirmation technique of paravertebral catheter tip location

Scientific Title

Evaluation of ultrasound-guided confirmation technique of paravertebral catheter tip location

Scientific Title:Acronym

Ultrasound-guided confirmation technique of paravertebral catheter tip location

Region

Japan


Condition

Condition

Unilateral video-assisted thoracic surgery

Classification by specialty

Chest surgery Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine accuracy of ultrasound-guided confirmation technique of paravertebral catheter tip location.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Success rate of a continuous thoracic paravertebral block

Key secondary outcomes

Spread of sensory block
Pain score
Incidence of PONV
Sedation scale
Incidence of local anesthetic systemic toxicity


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

20 years-old <=

Age-upper limit

80 years-old >

Gender

Male and Female

Key inclusion criteria

1. Patients undergoing a unilateral video-assisted surgery
2. American Society of Anesthesiologists PS: 1-3
3. Written informed consent is provided

Key exclusion criteria

1. Inability to communicate lucidly
2. Under 20 or over 80 years old
3. Postero-lateral thoracotomy reaching within 2 cm from the catheter insertion site
4. Inability to observe the paravertebral space under ultrasound
5. Body weight <40 kg
6. Contraindication or allergy to drugs used in this study
7. Pre-existing sensory disturbance of the trunk
8. Patients who are regarded ineligible by researchers with any other reasons

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kenta Furutani

Organization

Niigata University Graduate School of Medical and Dental Sciences

Division name

Division of Anesthesiology

Zip code


Address

1-757, Asahimachi-dori Chuo-ku Niigata, JAPAN

TEL

025-227-2328

Email

kenta-f@med.niigata-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Takayuki Yoshida

Organization

Niigata University Graduate School of Medical and Dental Sciences

Division name

Division of Anesthesiology

Zip code


Address

1-757, Asahimachi-dori Chuo-ku Niigata, JAPAN

TEL

025-227-2328

Homepage URL


Email

ytaka@mac.com


Sponsor or person

Institute

Niigata University Medical and Dental Hospital

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

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

新潟大学医歯学総合病院


Other administrative information

Date of disclosure of the study information

2014 Year 10 Month 31 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

2014 Year 11 Month 07 Day

Date of IRB


Anticipated trial start date

2014 Year 11 Month 07 Day

Last follow-up date

2016 Year 03 Month 31 Day

Date of closure to data entry

2016 Year 03 Month 31 Day

Date trial data considered complete

2016 Year 03 Month 31 Day

Date analysis concluded

2016 Year 03 Month 31 Day


Other

Other related information

Correlation of paravertebral block success rate and presence of catheter tip location confirmation under ultrasound guidance


Management information

Registered date

2014 Year 10 Month 31 Day

Last modified on

2018 Year 03 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017887


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name