UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical effectiveness of catheter-over-needle for postoperative pain management after TKA
Title of the study (Brief title)	Clinical settings of catheter-over-needle
Region	Japan

Condition
Condition	Total Knee Replacement
Classification by specialty	Orthopedics Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Efficacy of catheter-over-needle
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	leak of local anesthetic
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	total knee replacement
Key exclusion criteria	Not insertion of femoral nerve catheter
Target sample size	30

Research contact person
Name of lead principal investigator	Hironobu Ueshima
Organization	Showa university hospital
Division name	Anesthesiology
Address	1-5-8, hatanodai, shinagawa-ku, tokyo
TEL	03-3784-8575
Email	ueshimhi@yahoo.co.jp

Public contact
Name of contact person	Hironobu Ueshima
Organization	Showa university hospital
Division name	Anesthesiology
Address	1-5-8, hatanodai, shinagawa-ku, tokyo
TEL	03-3784-8575
Homepage URL
Email	ueshimhi@yahoo.co.jp

Sponsor
Institute	Showa university hospital
Institute
Department

Funding Source
Organization	Showa university hospital
Organization
Division
Category of Funding Organization	Other
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	2017 Year 01 Month 31 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2017 Year 01 Month 31 Day
Anticipated trial start date	2017 Year 01 Month 31 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	Patients received TKA from November to December, 2016 Leak of local anesthetic Extent of catheter lose

Management information
Registered date	2017 Year 01 Month 31 Day
Last modified on	2017 Year 01 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029820