UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032405 |
|---|---|
| Receipt number | R000036957 |
| Scientific Title | Utility of the TKA postoperative additional nerve block |
| Date of disclosure of the study information | 2018/05/01 |
| Last modified on | 2019/04/29 09:19:40 |
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Basic information
Public title
Utility of the TKA postoperative additional nerve block
Acronym
Utility of the TKA postoperative additional nerve block
Scientific Title
Utility of the TKA postoperative additional nerve block
Scientific Title:Acronym
Utility of the TKA postoperative additional nerve block
Region
| Japan |
Condition
Condition
Osteoarthritis of the knee joint
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We consider whether a postoperative additional nerve block is useful for TKA postoperative pain management
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pain VAS (0, 3, 6, 9, 12, 24, 36, 48h)
Postoperative pain-killer use
The days required for SLR
Change of the knee flexion angle
Frequency of the adverse event
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
additional femoral nerve block
20 ml of 0.25% levobupivacaine
is injected from an indwelling catheter
two days after surgery
Interventions/Control_2
no additional 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
| 50 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
OA knee joint planning primary TKA
Key exclusion criteria
simultaneous bilateral case
the case with the limit for medication
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Tomohiro |
| Middle name | |
| Last name | Ojima |
Organization
Fukui General Hospital
Division name
Dept. of Orthopaedic Surgery
Zip code
9108561
Address
58-16-1, Egami, Fukui
TEL
0776-59-1300
ojima@ka2.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Tomohiro |
| Middle name | |
| Last name | Ojima |
Organization
Fukui General Hospital
Division name
Dept. of Orthopaedic Surgery
Zip code
9108561
Address
58-16-1, Egami, Fukui
TEL
0776-59-1300
Homepage URL
ojima@ka2.so-net.ne.jp
Sponsor or person
Institute
Fukui General Hospital
Institute
Department
Personal name
Funding Source
Organization
Fukui General Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukui General Hospital
Address
58-16-1, Egami, Fukui
Tel
0776-59-1300
ojima@ka2.so-net.ne.jp
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
| 2018 | Year | 05 | 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
100
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
| 2018 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 04 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 04 | Month | 27 | Day |
Last modified on
| 2019 | Year | 04 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036957
