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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036227
Receipt No. R000041272
Scientific Title Analgesic efficacy of addition of obturator nerve block to femoral nerve block for total knee replacement
Date of disclosure of the study information 2019/03/17
Last modified on 2019/03/17

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Basic information
Public title Analgesic efficacy of addition of obturator nerve block to femoral nerve block for total knee replacement
Acronym Analgesic efficacy of addition of obturator nerve block to femoral nerve block for total knee replacement
Scientific Title Analgesic efficacy of addition of obturator nerve block to femoral nerve block for total knee replacement
Scientific Title:Acronym Analgesic efficacy of addition of obturator nerve block to femoral nerve block for total knee replacement
Region
Japan

Condition
Condition Total knee replacement
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Analgesic efficacy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Amount of fentanyl consumption in postoperative period
Key secondary outcomes Pain score

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 femoral and obturator nerve block
Interventions/Control_2 femoral nerve only
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 with the TKA
Key exclusion criteria patients without the TKA
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Hironobu
Middle name
Last name Ueshima
Organization Showa university hospital
Division name Anesthesiology
Zip code 142-8666
Address 1-5-8, hatanodai, shinagawa-ku, tokyo
TEL 03-3784-8575
Email ueshimhi@med.showa-u.ac.jp

Public contact
Name of contact person
1st name Hironobbu
Middle name
Last name Ueshima
Organization Showa university hospital
Division name Anesthesiology
Zip code 142-8666
Address 1-5-8, hatanodai, shinagawa-ku, tokyo
TEL 03-3784-8575
Homepage URL
Email ueshimhi@med.showa-u.ac.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)

IRB Contact (For public release)
Organization Showa university hospital
Address 1-5-8, hatanodai, shinagawa-ku, tokyo
Tel 03-3784-8575
Email ueshimhi@med.showa-u.ac.jp

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
2019 Year 03 Month 17 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 Preinitiation
Date of protocol fixation
2019 Year 03 Month 17 Day
Date of IRB
Anticipated trial start date
2019 Year 03 Month 30 Day
Last follow-up date
2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 03 Month 17 Day
Last modified on
2019 Year 03 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041272

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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