UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The Evaluation of new continuous peripheral nerve catheter
Title of the study (Brief title)	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	RIKA NOGAWA
Organization	Wakayama medical school
Division name	department of anesthesiology
Address	811-1, Kimiidera, Wakayama-city, Wakayama JAPAN
TEL	073-422-4714
Email	rikan@wakayama-med.ac.jp

Public contact
Name of contact person	RIKA NOGAWA
Organization	department of anesthesiology
Division name	department of anesthesiology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 07 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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