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

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 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

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

Value
https://center6.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