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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021910
Receipt No. R000025272
Scientific Title The opportune time for periarticular injection during total knee arthroplasty under general anesthesia: a randomized controlled trial
Date of disclosure of the study information 2016/04/14
Last modified on 2018/09/21

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Basic information
Public title The opportune time for periarticular injection during total knee arthroplasty under general anesthesia: a randomized controlled trial
Acronym The opportune time for periarticular injection during total knee arthroplasty under general anesthesia: a randomized controlled trial
Scientific Title The opportune time for periarticular injection during total knee arthroplasty under general anesthesia: a randomized controlled trial
Scientific Title:Acronym The opportune time for periarticular injection during total knee arthroplasty under general anesthesia: a randomized controlled trial
Region
Japan

Condition
Condition Osteoarthritis of the knee, rheumatoid arthritis, avascular necrosis
Classification by specialty
Orthopedics Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to compare the efficacy of periarticular injection between the superficial injection after the implantation of prosthesis and the superficial injection just prior to the arthrotomy in total knee arthroplasty under general anesthesia.
In the both groups, the deep injection is performed just prior to the implantation of prosthesis.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Pain score (Visual analogue scale) at recovery room
Key secondary outcomes Pain score (Visual analogue scale) 3 and 6 hours after surgery and 1 day after surgery
Blood loss
Complications
The consumption of remifentanil
The use of naloxone

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine Maneuver
Interventions/Control_1 Superficial injection after the implantation of prosthesis
Interventions/Control_2 Superficial injection just prior to the arthrotomy
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 unilateral total knee arthroplasty
Key exclusion criteria Patients scheduled for simultaneous bilateral total knee arthroplasty.
Patients who had allergy or intolerance to one of the study drugs, regular narcotic use, renal insufficiency and prolonged QT interval on ECG.
Target sample size 40

Research contact person
Name of lead principal investigator
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
Email s8058@nms.ac.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
2016 Year 04 Month 14 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://link.springer.com/article/10.1007%2Fs00167-018-5140-y
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
2016 Year 02 Month 17 Day
Date of IRB
Anticipated trial start date
2016 Year 09 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
2016 Year 04 Month 14 Day
Last modified on
2018 Year 09 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025272

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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