UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019177 |
|---|---|
| Receipt number | R000020709 |
| Scientific Title | The comparison of the efficasy of selective tibial nerve block and periarticular infiltration analgesia for total knee arthroplasty. |
| Date of disclosure of the study information | 2015/10/01 |
| Last modified on | 2017/10/06 09:43:43 |
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Basic information
Public title
The comparison of the efficasy of selective tibial nerve block and periarticular infiltration analgesia for total knee arthroplasty.
Acronym
The comparison of the efficasy of selective tibial nerve block and periarticular infiltration analgesia for total knee arthroplasty.
Scientific Title
The comparison of the efficasy of selective tibial nerve block and periarticular infiltration analgesia for total knee arthroplasty.
Scientific Title:Acronym
The comparison of the efficasy of selective tibial nerve block and periarticular infiltration analgesia for total knee arthroplasty.
Region
| Japan |
Condition
Condition
Osteoarthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the analgesic efficacy of selective tibial nerve block and periarticular infiltration analgesia for total knee arthroplasty when they are used with continuous femoral nerve block.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The postoperative pain score (VAS) in 48 hours.
The frequency of additional analgesics.
Key secondary outcomes
The frequency of postoperative peroneal nerve paralysis.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Perform selective tibial nerve block in addition to continuous femoral nerve block.
Interventions/Control_2
Perform periarticular infiltration analgesia in addition to continuous femoral nerve block.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients undergoing unilateral total knee arthroplasty.
Key exclusion criteria
The case the patient did not consent.
The critical organ failure like impairment of liver, kidney and heart.
The severe psychiatric disorder.
The patients taking analgesics except for knee pain.
Rheumatoid arthritis.
Any case with surgical complication intraoperatively.
The case of failed femoral nerve block or postoperative catheter trouble.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Katsuhiro Aikawa |
Organization
Hokkaido university
Division name
Department of anesthesiology
Zip code
Address
N15W7, Kita-ku, Sapporo, Hokkaido
TEL
011-706-7861(+81-11-706-7861)
katsuhiro.aikawa@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Katsuhiro Aikawa |
Organization
Hokkaido university
Division name
Department of anesthesiology
Zip code
Address
N15W7, Kita-ku, Sapporo, Hokkaido
TEL
011-706-7861(+81-11-706-7861)
Homepage URL
katsuhiro.aikawa@gmail.com
Sponsor or person
Institute
Hokkaido university. Department of anesthesiology.
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
砂川市立病院（北海道）/Sunagawa city medical center (Hokkaido)
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
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
Terminated
Date of protocol fixation
| 2014 | Year | 12 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 12 | Month | 08 | 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
| 2015 | Year | 09 | Month | 30 | Day |
Last modified on
| 2017 | Year | 10 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020709
