UMIN-CTR Clinical Trial

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
Last 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
1st 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