UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016015
Receipt number R000018572
Scientific Title Articular branches of the femoral nerve block; it`s analgesic efficacy on patients with proximal femoral fracture
Date of disclosure of the study information 2014/12/22
Last modified on 2017/08/18 16:22:54

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Basic information

Public title

Articular branches of the femoral nerve block; it`s analgesic efficacy on patients with proximal femoral fracture

Acronym

Articular branches of the femoral nerve block; it`s analgesic efficacy on patients with proximal femoral fracture

Scientific Title

Articular branches of the femoral nerve block; it`s analgesic efficacy on patients with proximal femoral fracture

Scientific Title:Acronym

Articular branches of the femoral nerve block; it`s analgesic efficacy on patients with proximal femoral fracture

Region

Japan


Condition

Condition

proximal femoral fractures

Classification by specialty

Orthopedics Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Proximal femoral fractures are more common in elderly people. Severe pain may lead to delirium and delay the recovery. Therefore, The purpose of this study was to assess the effectiveness of femoral nerve of articular branch.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Visual analog scale
Time to first analgesic drug use

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Femoral nerve of articular branch block

Interventions/Control_2

None

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

The patients whose American Society of Anesthesiologists Physical Status are 1-3, planned to Short-femoral-nail insertion and agree to Femoral nerve of articular branch block for postoperative analgesia are enrolled in this study.

Key exclusion criteria

Exclude criteria are the patients who have local anesthetic allergy or contrast agent allergy or peripheral neuropathy or coagulation abnormality.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takahiro Sugiura

Organization

National hospital organization Tokyo Medical Center

Division name

Anesthesiology

Zip code


Address

2-5-1, Higashigaoka Meguro-ku Tokyo 152-8902

TEL

03-3411-0111

Email

sugiura.takahiro@navy.plala.or.jp


Public contact

Name of contact person

1st name
Middle name
Last name Takahiro Sugiura

Organization

National hospital organization Tokyo Medical Center

Division name

Anesthesiology

Zip code


Address

2-5-1, Higashigaoka Meguro-ku Tokyo 152-8902

TEL

03-3411-0111

Homepage URL


Email

sugiura.takahiro@navy.plala.or.jp


Sponsor or person

Institute

National hospital organization Tokyo Medical Center

Institute

Department

Personal name



Funding Source

Organization

None

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


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

2014 Year 12 Month 22 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

Terminated

Date of protocol fixation

2014 Year 12 Month 10 Day

Date of IRB


Anticipated trial start date

2014 Year 12 Month 22 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 12 Month 20 Day

Last modified on

2017 Year 08 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018572


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name