UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026776 |
|---|---|
| Receipt number | R000030730 |
| Scientific Title | Fluoroscopic guided-catheter insertion method for continuous femoral nerve block for analgesia after total knee arthroplasty: a prospective, one institutional, interventional study |
| Date of disclosure of the study information | 2017/04/14 |
| Last modified on | 2019/04/07 21:47:50 |
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Basic information
Public title
Fluoroscopic guided-catheter insertion method for continuous femoral nerve block for analgesia after total knee arthroplasty: a prospective, one institutional, interventional study
Acronym
Fluoroscopic guided-catheter insertion method for continuous femoral nerve block for analgesia after total knee arthroplasty
Scientific Title
Fluoroscopic guided-catheter insertion method for continuous femoral nerve block for analgesia after total knee arthroplasty: a prospective, one institutional, interventional study
Scientific Title:Acronym
Fluoroscopic guided-catheter insertion method for continuous femoral nerve block for analgesia after total knee arthroplasty
Region
| Japan |
Condition
Condition
Osteoarthritis of the knee
Classification by specialty
| Orthopedics | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of fluoroscopic guided-catheter insertion technique for continuous femoral nerve block for analgesia after total knee arthroplasty
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of minimum current perception thresholds at four nerve-dominated areas (femoral nerve, obturator nerve, lateral femoral cutaneous nerve, sciatic nerve) on postoperative day 1, 3, and 6
Key secondary outcomes
Complications
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
This technique is performed after spinal anesthesia preoperatively. A catheter is inserted from the outside of the femoral artery just below the inguinal ligament following confirmation of the position of the femoral nerve with a nerve stimulator. Subsequently, the catheter is cautiously advanced through a 50cm guide wire to the level of L5 under fluoroscopic guidance. The position of the catheter is confirmed with 10ml of a contrast agent in the frontal view of an X ray at the hip joint. After the operation, 0.2% ropivacaine is continuously administered at 5 ml/hr and then 0.125% ropivacaine is administered on postoperative day 2 through the catheter and until postoperative day 4, when the catheter is removed.
Interventions/Control_2
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients planning to total knee arthroplasty
Key exclusion criteria
Allergy to local anesthetic agents
Bleeding tendency
Severe liver dysfunction
Severe renal dysfunction
Incorporation to treatment
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Toshio |
| Middle name | |
| Last name | Iwaki |
Organization
Matsuda Hospital
Division name
Department of Anesthesiology
Zip code
710-0056
Address
1-3-10, tsurugata, Kurashiki-shi, Okayama, Japan
TEL
086-422-3550
tenwaans@mx1.kct.ne.jp
Public contact
Name of contact person
| 1st name | Toshio |
| Middle name | |
| Last name | Iwaki |
Organization
Matsuda Hospital
Division name
Department of Anesthesiology
Zip code
710-0056
Address
1-3-10, tsurugata, Kurashiki-shi, Okayama, Japan
TEL
086-422-3550
Homepage URL
tenwaans@mx1.kct.ne.jp
Sponsor or person
Institute
Matsuda Hospital
Institute
Department
Personal name
Funding Source
Organization
Matsuda 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
Matsuda Hospital
Address
1-3-10, tsurugata, Kurashiki-shi, Okayama, Japan
Tel
086-422-3550
tenwaans@mx1.kct.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
天和会 松田病院（岡山県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 04 | Month | 14 | 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
25
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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 03 | Month | 29 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 29 | Day |
Anticipated trial start date
| 2017 | Year | 03 | Month | 29 | Day |
Last follow-up date
| 2019 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2019 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2019 | Year | 04 | Month | 15 | Day |
Date analysis concluded
| 2019 | Year | 04 | Month | 15 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 03 | Month | 30 | Day |
Last modified on
| 2019 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030730
