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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025598
Receipt No. R000029462
Scientific Title Ultrasound-guided peripheral nerve block versus periarticular injection for pain management after TKA: randomised controlled trial
Date of disclosure of the study information 2017/01/10
Last modified on 2018/04/28

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Basic information
Public title Ultrasound-guided peripheral nerve block versus periarticular injection for pain management after TKA: randomised controlled trial
Acronym Ultrasound-guided peripheral nerve block versus periarticular injection: randomised controlled trial
Scientific Title Ultrasound-guided peripheral nerve block versus periarticular injection for pain management after TKA: randomised controlled trial
Scientific Title:Acronym Ultrasound-guided peripheral nerve block versus periarticular injection: randomised controlled trial
Region
Japan

Condition
Condition Osteoarthritis of knee joint
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare ltrasound-guided peripheral nerve blocks versus periarticular injections for pain management after TKA
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Pain scale evaluated with 100-mm visual analogue scale (postop.0,2,4,6,8,10,12,18,24,36,48,72h)
Key secondary outcomes Time of anaesthesia
Narcotic use
Quadriceps function
Range of motion of knee joint
Complication

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved 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 peripheral nerve block
Interventions/Control_2 periarticular injection
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 Patients having knee osteoarthritis scheduled primary TKA
Key exclusion criteria Patients scheduled simultaneous bilateral TKA
Patients with the drug allergy
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomohiro Ojima
Organization Fukui General Hospital
Division name Orthopaedic surgery
Zip code
Address 58-16-1 Egami, Fukui, 910-8561, JAPAN
TEL 0776-59-1300
Email ojima@ka2.so-net.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomohiro Ojima
Organization Fukui General Hospital
Division name Orthopaedic surgery
Zip code
Address 58-16-1 Egami, Fukui, 910-8561, JAPAN
TEL 0776-59-1300
Homepage URL
Email ojima@ka2.so-net.ne.jp

Sponsor
Institute Fukui General Hospital
Institute
Department

Funding Source
Organization Fukui General Hospital
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 01 Month 10 Day

Related information
URL releasing protocol
Publication of results Published

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
2017 Year 01 Month 04 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 05 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 01 Month 10 Day
Last modified on
2018 Year 04 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029462

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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