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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019895
Receipt No. R000021591
Scientific Title The Evaluation of new continuous peripheral nerve catheter
Date of disclosure of the study information 2015/11/23
Last modified on 2019/02/25

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Basic information
Public title The Evaluation of new continuous peripheral nerve catheter
Acronym The Evaluation of new continuous peripheral nerve catheter
Scientific Title The Evaluation of new continuous peripheral nerve catheter
Scientific Title:Acronym The Evaluation of new continuous peripheral nerve catheter
Region
Japan

Condition
Condition Osteoarthritis , Injuries of leg, anterior cruciate ligament meniscus , Fracture
Classification by specialty
Orthopedics Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 No leakage of medicaments with new continuous peripheral nerve catheters compared with former catheters.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The existence of leakage of medicaments
Key secondary outcomes height , weight , sex , duration time of block

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 We do peripheral nerve block to femoral nerve with new catheter ( catheter over needle : CON ) after surgery as postoperative analgesia until the morning of the next day.
The mendicant is popscaine as local anesthesia.
We give patients to PCA ( patient controlled analgesia , base 5ml / h. rock out time 30 min. bolus 3ml , 0.25% popscaine 100ml + saline 100ml ) systems.
Interventions/Control_2 We do peripheral nerve block to femoral nerve with new catheter ( catheter through needle : CTN ) after surgery as postoperative analgesia until the morning of the next day.
The mendicant is popscaine as local anesthesia.
We give patients to PCA ( patient controlled analgesia , base 5ml / h. rock out time 30 min. bolus 3ml , 0.25% popscaine 100ml + saline 100ml ) systems.
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 be comprehensible to the study
Key exclusion criteria be incomprehensible to the study
not well- fed ( alb mine is under 3.0 )
BMI ( body mass index ) is above 35
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 department of anesthesiology
Zip code
Address 811-1, Kimiidera, Wakayama-city, Wakayama JAPAN
TEL 073-422-4714
Email rikan@wakayama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name RIKA NOGAWA
Organization department of anesthesiology
Division name department of anesthesiology
Zip code
Address 811-1, Kimiidera, Wakayama-city, Wakayama JAPAN
TEL 073-422-4714
Homepage URL
Email rikan@wakayama-med.ac.jp

Sponsor
Institute Department of anesthesiology , Wakayama medical school
Institute
Department

Funding Source
Organization Department of anesthesiology , Wakayama medical school
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization Japan

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 和歌山県立医科大学付属病院

Other administrative information
Date of disclosure of the study information
2015 Year 11 Month 23 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 07 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 07 Month 01 Day
Last follow-up date
2017 Year 07 Month 01 Day
Date of closure to data entry
2017 Year 12 Month 31 Day
Date trial data considered complete
2017 Year 12 Month 31 Day
Date analysis concluded
2018 Year 07 Month 01 Day

Other
Other related information

Management information
Registered date
2015 Year 11 Month 22 Day
Last modified on
2019 Year 02 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021591

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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