UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A clinical evaluation of new catheter for continuous peripheral nerve block
Title of the study (Brief title)	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	Rika Nogawa
Organization	Wakayama medical school
Division name	anesthegiology
Address	Kimiidera 811-1 , Wakayama city , Wakayama
TEL	073-447-2300
Email	rikan@wakayama-med.ac.jp

Public contact
Name of contact person	Rika Nogawa
Organization	Wakayama medical school
Division name	anesthesiology
Address	Kimiidera 811-1 , Wakayama city , Wakayama
TEL	073-447-2300
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	Self funding
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information	2015 Year 11 Month 04 Day

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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022692