UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019630
Receipt number R000022692
Scientific Title A clinical evaluation of new catheter for continuous peripheral nerve block
Date of disclosure of the study information 2015/11/04
Last modified on 2019/02/25 15:07:12

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Basic information

Public title

A clinical evaluation of new catheter for continuous peripheral nerve block

Acronym

A clinical evaluation of new catheter for continuous peripheral nerve block

Scientific Title

A clinical evaluation of new catheter for continuous peripheral nerve block

Scientific Title:Acronym

A clinical evaluation of new catheter for continuous peripheral nerve block

Region

Japan


Condition

Condition

osteoarthritis

Classification by specialty

Orthopedics Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate of leakage of local anesthetics with new catheter for peripheral nerve block

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The existence of leakage of local anesthetics

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


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

Device,equipment

Interventions/Control_1

new catheter of peripheral nerve block

Interventions/Control_2

past catheter of peripheral nerve 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


Not applicable

Gender

Male and Female

Key inclusion criteria

undergone for total knee replacement

Key exclusion criteria

obesity
be incomprehensible
emaciation

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Rika Nogawa

Organization

Wakayama medical school

Division name

anesthegiology

Zip code


Address

Kimiidera 811-1 , Wakayama city , Wakayama

TEL

073-447-2300

Email

rikan@wakayama-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Rika Nogawa

Organization

Wakayama medical school

Division name

anesthesiology

Zip code


Address

Kimiidera 811-1 , Wakayama city , Wakayama

TEL

073-447-2300

Homepage URL


Email

rikan@wakayama-med.ac.jp


Sponsor or person

Institute

Department of Anesthesiology , Wakayama medical school

Institute

Department

Personal name



Funding Source

Organization

Department of Anesthesiology , Wakayama medical school

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



Other administrative information

Date of disclosure of the study information

2015 Year 11 Month 04 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 07 Month 01 Day

Date of IRB


Anticipated trial start date

2015 Year 07 Month 01 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 11 Month 04 Day

Last modified on

2019 Year 02 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022692


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name