UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011181 |
|---|---|
| Receipt number | R000013096 |
| Scientific Title | Continuous epidural infusion versus periarticular multimodal drug injection in bilateral simultaneous total knee arthroplasty: a randomized controlled trial |
| Date of disclosure of the study information | 2013/07/12 |
| Last modified on | 2015/03/07 19:13:36 |
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Basic information
Public title
Continuous epidural infusion versus periarticular multimodal drug injection in bilateral simultaneous total knee arthroplasty: a randomized controlled trial
Acronym
Continuous epidural infusion versus periarticular multimodal drug injection in bilateral simultaneous total knee arthroplasty: a randomized controlled trial
Scientific Title
Continuous epidural infusion versus periarticular multimodal drug injection in bilateral simultaneous total knee arthroplasty: a randomized controlled trial
Scientific Title:Acronym
Continuous epidural infusion versus periarticular multimodal drug injection in bilateral simultaneous total knee arthroplasty: a randomized controlled trial
Region
| Japan |
Condition
Condition
Osteoarthritis of knee, rheumatoid arthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the continuous epidural infusion and periarticular multimodal drug injection for pain after bilateral simultaneous total knee arthroplasty.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visual analogue scale score for postoperative pain at rest.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
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
A continuous epidural infusion containing ropivacaine and morphine for pain after simultaneous bilateral total knee arthroplasty
Interventions/Control_2
A periarticular multimodal drug injection including ropivacaine, morphine, bosmin, methylprednisolone, and ketoprofen for pain after simultaneous bilateral 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 simultaneous bilateral total knee arthroplasty.
Key exclusion criteria
Patients who had contraindications to spinal anaesthesia and epidural analgesia, allergy or intolerance to one of the study drugs, regular narcotic use, renal insufficiency and prolonged QT interval on ECG.
Target sample size
60
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
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
s8058@nms.ac.jp
Sponsor or person
Institute
Nekoyama miyao hospital
Institute
Department
Personal name
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
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
| 2013 | Year | 07 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://jbjs.org/content/97/5/367
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 | 09 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 11 | Month | 19 | 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 | 07 | Month | 12 | Day |
Last modified on
| 2015 | Year | 03 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013096
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
