UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019895 |
|---|---|
| Receipt number | 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 14:42:38 |
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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
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
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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021591
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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