UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031561
Receipt number R000035857
Scientific Title Investigation of Simple Continuous Injection Pressure Measurement Method for Femoral Nerve Block
Date of disclosure of the study information 2018/03/05
Last modified on 2019/09/03 06:25:54

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Basic information

Public title

Investigation of Simple Continuous Injection Pressure Measurement Method for Femoral Nerve Block

Acronym

Investigation of Simple Continuous Injection Pressure Measurement Method for Femoral Nerve Block

Scientific Title

Investigation of Simple Continuous Injection Pressure Measurement Method for Femoral Nerve Block

Scientific Title:Acronym

Investigation of Simple Continuous Injection Pressure Measurement Method for Femoral Nerve Block

Region

Japan


Condition

Condition

femoral nerve block

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

It is possible to use femoral nerve block with injection pressure of 0-15 PSI by simple continuous injection pressure measurement method

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

percentage of completion of local anesthesic injection within target pressure range

Key secondary outcomes



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

Interventions/Control_1

The dose of local anesthetic is set to 5 ml once, and a total of three measurements are made for each patient. Calculate the maximum injection pressure during each medical solution from the compression rate of the recorded air. When air compression indicating 15 PSI or more is confirmed, administration of chemical solution is promptly stopped after checking the injection pressure at that time. Change the puncture position to continue nerve block, measure subsequent injection pressures up to 3 times.



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


Not applicable

Gender

Male and Female

Key inclusion criteria

adult patients undergoing orthpedic surgery for femoral fractures or pattella fracture.
patients with sufficient understanding and consent after receiving an explanation of injection pressure measurement at the femoral nerve block

Key exclusion criteria

patients whose neurological block was judged inappropriate by the attending physician

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroshi Kondo

Organization

Higashihiroshima medical center

Division name

department of anesthesiology

Zip code


Address

513, Saijyocho Jike, Higashihiroshima-shi,Hiroshima,739-0041,Japan

TEL

0824232176

Email

h.kondo1986@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Hiroshi Kondo

Organization

Higashihiroshima medical center

Division name

department of anesthesiology

Zip code


Address

513, Saijyocho Jike, Higashihiroshima-shi,Hiroshima,739-0041,Japan

TEL

0824232176

Homepage URL


Email

h.kondo1986@gmail.com


Sponsor or person

Institute

Higashihiroshima medical center

Institute

Department

Personal name



Funding Source

Organization

Higashihiroshima medical center

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

2018 Year 03 Month 05 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

2018 Year 03 Month 03 Day

Date of IRB

2018 Year 02 Month 14 Day

Anticipated trial start date

2018 Year 03 Month 05 Day

Last follow-up date

2019 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 03 Month 03 Day

Last modified on

2019 Year 09 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035857


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name