UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023679 |
|---|---|
| Receipt number | R000027272 |
| Scientific Title | Study about the optimum location of continuous femoral nerve catheter tip |
| Date of disclosure of the study information | 2016/09/01 |
| Last modified on | 2018/05/22 16:36:54 |
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Basic information
Public title
Study about the optimum location of continuous femoral nerve catheter tip
Acronym
Study about the optimum location of continuous femoral nerve catheter tip
Scientific Title
Study about the optimum location of continuous femoral nerve catheter tip
Scientific Title:Acronym
Study about the optimum location of continuous femoral nerve catheter tip
Region
| Japan |
Condition
Condition
knee osteoarthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The continuous femoral nervous block (CFNB) catheter is being placed in the sharp pain reduction purpose after an operation of an artificial knee joint replacement (TKA) at our hospital. A study about the optimum location of the CFNB catheter is being planned this time. Object is roughly divided into 2 groups from its location. So that a catheter point may be detained in 2 points different in a thigh nerve using nervous stimulus equipment. It's expected to compare and examine VAS value after an operation (the expression evaluation scale) and the knee deformed (It's caused by numbness of the movement range of the thigh nerve mainly.) occurrence rate, etc. between 2 flights.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
VAS value to 3POD (the maximum during one day)
Key secondary outcomes
(1) The use number of times of the help anodyne medicine after an operation
(2) The PONV occurrence rate after an operation
(3) CPM in 2 POD-6 POD
(4) The ROM which will be 1 month later (at the time of leaving) after an operation (the joint mobile level of the knee)
(5) The help anodyne medicine opening time after an operation
(6) Presence of the numbness after an operation
(7) The occurrence rate of the knee collapse (the value of the motor function)
(8) The occurrence rate of the catheter trouble
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
We divided into two groups by the position of the thigh nervous block catheter.
The two groups positioned a catheter as follows after thigh nervous distinction under the ultrasonic guide.
An A group positioned the catheter in the center of 1/2 inside the thigh nervous underside.
A nervous block of single time is carried out in the part (0.25% levobupivacaine 20ml use).
After doing tape fixing of a CFNB catheter, the continuous nervous block for 3 days (0.125% Ropivacaine 4ml/h use) is performed after an operation from operation end verge.
VAS value to 3POD, CPM to 6POD and the ROM which will be 1 month later after an operation are measured after an operation.
Interventions/Control_2
We divided into two groups by the position of the thigh nervous block catheter.
The two groups positioned a catheter as follows after thigh nervous distinction under the ultrasonic guide.
B group positioned the catheter in the center of 1/2 outside the thigh nervous underside.
A nervous block of single time is carried out in the part (0.25% levobupivacaine 20ml use).
After doing tape fixing of a CFNB catheter, the continuous nervous block for 3 days (0.125% Ropivacaine 4ml/h use) is performed after an operation from operation end verge.
VAS value to 3POD, CPM to 6POD and the ROM which will be 1 month later after an operation are measured after an operation.
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Among the knee arthropathy patient who receives TKA under the general anesthesia and the patient who fills ASA (state classification before the American anesthesiology meeting way) 1 -2 with the 20 years old-80 years old of age.
Key exclusion criteria
The case which couldn't positioned a catheter in predetermined position
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | asami machino |
Organization
chubu-rosai hospital
Division name
anesthesiology
Zip code
Address
1-10-6, koumei, minato-ku, nagoya city
TEL
0526525511
mwgendarme@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | asami machino |
Organization
chubu-rosai hospital
Division name
anesthesiology
Zip code
Address
1-10-6, koumei, minato-ku, nagoya city
TEL
0526525511
Homepage URL
mwgendarme@yahoo.co.jp
Sponsor or person
Institute
chubu-rosai hospital
Institute
Department
Personal name
Funding Source
Organization
chubu-rosai 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
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
| 2016 | Year | 09 | 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
Completed
Date of protocol fixation
| 2016 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2019 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
| 2019 | Year | 09 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 08 | Month | 18 | Day |
Last modified on
| 2018 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027272
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