UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045374 |
|---|---|
| Receipt number | R000051366 |
| Scientific Title | Dislocation rates of femoral triangle catheters placed either perpendicular or parallel to the nerve. |
| Date of disclosure of the study information | 2021/09/03 |
| Last modified on | 2023/09/13 17:24:10 |
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Basic information
Public title
Dislocation rates of femoral triangle catheters placed either perpendicular or parallel to the nerve.
Acronym
Dislocation rates of femoral triangle catheters placed either perpendicular or parallel to the nerve.
Scientific Title
Dislocation rates of femoral triangle catheters placed either perpendicular or parallel to the nerve.
Scientific Title:Acronym
Dislocation rates of femoral triangle catheters placed either perpendicular or parallel to the nerve.
Region
| Japan |
Condition
Condition
TKA
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the dislocation rates of femoral triangle catheters placed perpendicularly or parallel to the nerve.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Dislocation rates of femoral triangle catheters after physical therapy on postoperative day 2.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Femoral triangle catheter placed parallel to the nerve.
Interventions/Control_2
Femoral triangle catheter placed perpendicular to the nerve.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. patients scheduled unilateral total knee arthroplasty
2. patients over 20 years old
3. Patients with American Society of Anesthesiologist (ASA) physical status I-III
Key exclusion criteria
1. Patients scheduled bilateral TKA
2. Revision knee arthroplasty
3. Preoperative neurological disability of the lower limbs
4. Chronic opioid use
5. patients with allergy to local anesthetics
6. patients with poor capacity for consent
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Fujino |
Organization
Kansai Medical University Hospital
Division name
Dep. Anesthesiology
Zip code
573-1191
Address
2-3-1, Shinmachi, Hirakata, Osaka, Japan
TEL
072-804-0101
t-fujino@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Fujino |
Organization
Kansai Medical University Hospital
Division name
Dep. Anesthesiology
Zip code
0042
Address
2-3-1, Shinmachi, Hirakata, Osaka, Japan
TEL
072-804-0101
Homepage URL
t-fujino@juntendo.ac.jp
Sponsor or person
Institute
Kansai Medical University Hospital
Institute
Department
Personal name
Funding Source
Organization
Kansai Medical University Hospital
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
Kansai Medical University Hospital
Address
2-3-1, Shinmachi, Hirakata, Osaka, Japan
Tel
072-804-0101
t-fujino@juntendo.ac.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
| 2021 | Year | 09 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
70
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
| 2021 | Year | 08 | Month | 25 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 16 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 14 | Day |
Last follow-up date
| 2022 | Year | 05 | Month | 19 | Day |
Date of closure to data entry
| 2022 | Year | 06 | Month | 18 | Day |
Date trial data considered complete
| 2022 | Year | 06 | Month | 18 | Day |
Date analysis concluded
| 2022 | Year | 07 | Month | 27 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 09 | Month | 03 | Day |
Last modified on
| 2023 | Year | 09 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051366
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| Registered date | File name |
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| Registered date | File name |
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