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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016479
Receipt No. R000019140
Scientific Title Pain control after simultaneous bilateral total hip arthroplasty: a randomized controlled trial comparing periarticular injection in one hip and placebo in another hip
Date of disclosure of the study information 2015/02/09
Last modified on 2018/06/26

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Basic information
Public title Pain control after simultaneous bilateral total hip arthroplasty: a randomized controlled trial comparing periarticular injection in one hip and placebo in another hip
Acronym Pain control after simultaneous bilateral total hip arthroplasty: a randomized controlled trial comparing periarticular injection in one hip and placebo in another hip
Scientific Title Pain control after simultaneous bilateral total hip arthroplasty: a randomized controlled trial comparing periarticular injection in one hip and placebo in another hip
Scientific Title:Acronym Pain control after simultaneous bilateral total hip arthroplasty: a randomized controlled trial comparing periarticular injection in one hip and placebo in another hip
Region
Japan

Condition
Condition Osteoarthritis of the hip, rheumatoid arthritis, avascular necrosis of the femoral head
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the efficacy of periarticular injection in total hip arthroplasty.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Pain after total hip arthroplasty (evaluated with visual analogue scale)
Key secondary outcomes Complication

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
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 One hip is received intraoperative periarticular injections during simultaneous bilateral total hip arthroplasty
Interventions/Control_2 Another hip is received intraoperative normal saline injections during simultaneous bilateral total hip arthroplasty
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients scheduled for simultaneous bilateral total hip arthroplasty
Key exclusion criteria Patients with ASA status III-V, renal insufficiency, hepatic insufficiency, prolonged QT interval on electrocardiograms, and allergy or intolerance to one of the study drugs.
Target sample size 17

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoyuki Hirasawa
Organization Hokusuikai kinen hospital
Division name Orthopaedic surgery
Zip code
Address 3-2-1 Higashihara, Mito, Ibaraki, 310-0035 Japan
TEL 029-303-3003
Email hirari3@orion.ocn.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Sachiyuki Tsukada
Organization Hokusuikai kinen hospital
Division name Orthopaedic surgery
Zip code
Address 3-2-1 Higashihara, Mito, Ibaraki, 310-0035 Japan
TEL 029-303-3003
Homepage URL
Email s8058@nms.ac.jp

Sponsor
Institute Hokusuikai kinen hospital
Institute
Department

Funding Source
Organization Hokusuikai kinen 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
2015 Year 02 Month 09 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pubmed/29939894
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
2015 Year 02 Month 07 Day
Date of IRB
Anticipated trial start date
2015 Year 02 Month 09 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information https://journals.lww.com/clinorthop/Abstract/publishahead/No_Clinically_Important_Difference_in_Pain_Scores.98464.aspx

Management information
Registered date
2015 Year 02 Month 09 Day
Last modified on
2018 Year 06 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019140

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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