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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034649
Receipt No. R000039504
Scientific Title Efficacy of PENG block for THA
Date of disclosure of the study information 2018/10/25
Last modified on 2019/04/26

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Basic information
Public title Efficacy of PENG block for THA
Acronym Efficacy of PENG block for THA
Scientific Title Efficacy of PENG block for THA
Scientific Title:Acronym Efficacy of PENG block for THA
Region
Japan

Condition
Condition THA
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

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

Assessment
Primary outcomes the total cummlative fentanyl within 24 hours after the surgery
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
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
Maneuver
Interventions/Control_1 Lumbar plexus nerve block group
Interventions/Control_2 PENG block group
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 THA patients
Key exclusion criteria no THA patients
Target sample size 60

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 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
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
Address 1-5-8, hatanodai, shinagawa, tokyo
Tel 03-3784-8575
Email ueshimhii@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
2018 Year 10 Month 25 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
2018 Year 10 Month 25 Day
Date of IRB
2018 Year 10 Month 25 Day
Anticipated trial start date
2018 Year 10 Month 25 Day
Last follow-up date
2020 Year 03 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
2018 Year 10 Month 25 Day
Last modified on
2019 Year 04 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039504

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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