UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010902 |
|---|---|
| Receipt number | 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 20:17:24 |
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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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012757
