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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027987
Receipt No. R000032052
Scientific Title Analgesic efficacy of ultrasound-guided continuous femoral nerve block in two different catheter tip locations for total knee arthroplasty: a randomized controlled study
Date of disclosure of the study information 2017/10/01
Last modified on 2018/02/09

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Basic information
Public title Analgesic efficacy of ultrasound-guided continuous femoral nerve block in two different catheter tip locations for total knee arthroplasty: a randomized controlled study
Acronym Two different catheter tip locations of ultrasound-guided continuous femoral nerve block: a randomized controlled study
Scientific Title Analgesic efficacy of ultrasound-guided continuous femoral nerve block in two different catheter tip locations for total knee arthroplasty: a randomized controlled study
Scientific Title:Acronym Two different catheter tip locations of ultrasound-guided continuous femoral nerve block: a randomized controlled study
Region
Japan

Condition
Condition knee osteoarthritis
Classification by specialty
Orthopedics Anesthesiology Operative medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Verifying analgesic efficacy of ultrasound-guided continuous femoral nerve block in two different catheter tip locations for total knee arthroplasty
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Numerical Rating Scale (NRS) at 0, 3, 6, 12, 24 and 40h after surgery
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Ultrasound-guided continuous femoral nerve block, catheter tip placed anterior to the femoral nerve
Interventions/Control_2 Ultrasound-guided continuous femoral nerve block, catheter tip placed posterior to the femoral nerve
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
85 years-old >=
Gender Male and Female
Key inclusion criteria ASA-PS status 1 to 3
Patients undergoing total knee arthroplasty
Key exclusion criteria Allergy to local anesthetics
Coagulation disorders
Target sample size 70

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Taro Fujitani
Organization Ehime prefectural central hospiatal
Division name Department of anesthesiology and clitical care
Zip code
Address 83 Kasuga-cho Matsuyama-city, Ehime 790-0024
TEL +81-89-947-1111
Email cyuirisawa@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yumi Irisawa
Organization Ehime prefectural central hospiatal
Division name Department of anesthesiology and clitical care
Zip code
Address 83 Kasuga-cho Matsuyama-city, Ehime 790-0024
TEL +81-89-947-1111
Homepage URL
Email cyuirisawa@yahoo.co.jp

Sponsor
Institute Ehime prefectural central hospiatal
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2017 Year 10 Month 01 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 Open public recruiting
Date of protocol fixation
2017 Year 08 Month 10 Day
Date of IRB
Anticipated trial start date
2017 Year 10 Month 02 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 06 Month 28 Day
Last modified on
2018 Year 02 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032052

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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