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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023679
Receipt No. 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

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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
Email 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
Email mwgendarme@yahoo.co.jp

Sponsor
Institute chubu-rosai hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027272

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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