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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010902
Receipt No. R000012757
Scientific Title A randomized controlled trial comparing epidural anesthesia and periarticular multimodal drug injection for total knee arthroplasty
Date of disclosure of the study information 2013/06/07
Last modified on 2014/09/04

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Basic information
Public title A randomized controlled trial comparing epidural anesthesia and periarticular multimodal drug injection for total knee arthroplasty
Acronym A randomized controlled trial comparing epidural anesthesia and periarticular multimodal drug injection for total knee arthroplasty
Scientific Title A randomized controlled trial comparing epidural anesthesia and periarticular multimodal drug injection for total knee arthroplasty
Scientific Title:Acronym A randomized controlled trial comparing epidural anesthesia and periarticular multimodal drug injection for total knee arthroplasty
Region
Japan

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

Objectives
Narrative objectives1 To compare the epidural anesthesia and periarticular multimodal drug injection for pain after total knee arthroplasty.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Visual analog scale score at rest at 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 32, 40, 48, 56, 64, and 72 hour after the time of complete resolution of the spinal anesthetic.
Key secondary outcomes Visual analog scale during activity.
Complication including nausea/vomitting, skin necrosis, pruritis, respiratory depression, peroneus nerve pulsy and sugical site infection.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine Maneuver
Interventions/Control_1 An epidural anesthesia containing 2mg/ml ropivacaine 100ml and 10mg/ml morphine 0.8ml for pain after total knee arthroplasty
Interventions/Control_2 A periarticular multimodal drug injection including 7.5mg/ml ropivacaine, 10mg/ml morphine 0.8ml, bosmin 0.3mg, methylprednisolone 40mg, and ketoprofen 50mg for pain after total knee 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 primary unilateral total knee arthroplasty.
Key exclusion criteria Patients scheduled for simultaneous bilateral total knee arthroplasty.
Patients who need the heparinization perioperative period.
Patients have allergy or intolerance to one of the study drugs, renal insufficiency and prolonged QT interval on ECG.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Sachiyuki Tsukada
Organization Nekoyama miyao hospital
Division name Orthopaedic surgery
Zip code
Address 14-7 Konan, Chuo-ku, Niigata, Niigata, 950-1151 Japan
TEL 025-282-2323
Email s8058@nms.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Sachiyuki Tsukada
Organization Nekoyama miyao hospital
Division name Orthopaedic surgery
Zip code
Address 14-7 Konan, Chuo-ku, Niigata, Niigata, 950-1151 Japan
TEL 025-282-2323
Homepage URL
Email s8058@nms.ac.jp

Sponsor
Institute Nekoyama miyao hospital
Institute
Department

Funding Source
Organization None
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 猫山宮尾病院(新潟県)

Other administrative information
Date of disclosure of the study information
2013 Year 06 Month 07 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://jbjs.org/content/96/17/1433
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
2012 Year 06 Month 25 Day
Date of IRB
Anticipated trial start date
2012 Year 07 Month 11 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
2013 Year 06 Month 07 Day
Last modified on
2014 Year 09 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012757

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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