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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000026776
Receipt No. 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

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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
Email 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
Email tenwaans@mx1.kct.ne.jp

Sponsor
Institute Matsuda Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030730

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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