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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025774
Receipt No. R000029646
Scientific Title Investigation of Programmed Intermittent Bolus of Lumbar Plexus Block for Total Hip Arthroplasty
Date of disclosure of the study information 2017/02/01
Last modified on 2018/04/02

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Basic information
Public title Investigation of Programmed Intermittent Bolus of Lumbar Plexus Block for Total Hip Arthroplasty
Acronym Investigation of PIB of LPB for THA
Scientific Title Investigation of Programmed Intermittent Bolus of Lumbar Plexus Block for Total Hip Arthroplasty
Scientific Title:Acronym Investigation of PIB of LPB for THA
Region
Japan

Condition
Condition Total Hip Arthroplasty
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Investigation of effective analgesia
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Number of pushed PCEA
The amount of fentanyl
Key secondary outcomes Number of requested PCEA
Number of patients used additional analgesi

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 The set flow rate was continuous 6mL of levobupivacaine 0.1% every hour and 6mL levobupivacaine 0.1% lock out time: 60 minutes for 2 days.
Interventions/Control_2 The set flow rate was intermittent bolus of 12mL of levobupivacaine 0.1% every 2 hours and 6mL levobupivacaine 0.1% lock out time: 60 minutes for 2 days.
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
80 years-old >
Gender Male and Female
Key inclusion criteria Patients who schedule THA
Key exclusion criteria secondary surgery
bilateral THA
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hironobu Ueshima
Organization Showa University Hospital
Division name Anesthesiology
Zip code
Address 1-5-8, Hatanodai, Shinagawa-ku, Tokyo, 142-8666 Japan
TEL 0337848575
Email ueshimhi@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hironobu Ueshima
Organization Showa University Hospital
Division name Anesthesiology
Zip code
Address 1-5-8, Hatanodai, Shinagawa-ku, Tokyo, 142-8666 Japan
TEL 0337848575
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)

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 02 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 Completed
Date of protocol fixation
2017 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 02 Month 01 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 20 Day
Last modified on
2018 Year 04 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029646

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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