UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000002203
Receipt number R000002707
Scientific Title Study on the efficacy of ultrasound-guided nerve blockade
Date of disclosure of the study information 2009/07/15
Last modified on 2016/06/10 11:34:48

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Study on the efficacy of ultrasound-guided nerve blockade

Acronym

Study on the efficacy of ultrasound-guided nerve blockade

Scientific Title

Study on the efficacy of ultrasound-guided nerve blockade

Scientific Title:Acronym

Study on the efficacy of ultrasound-guided nerve blockade

Region

Japan


Condition

Condition

Patients undergoing surgery under nerve blocks

Classification by specialty

Surgery in general Obstetrics and Gynecology Dermatology
Orthopedics Urology Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the effecacy and adverse effects of ultrasound-guided regional anesthesia using patients undergoing surgery

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Sensory and motor blockade, success rate, onset time, duration, side effects

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Each approach of the brachial plexus block

Interventions/Control_2

thoracic paravertebral block

Interventions/Control_3

Ultrasound-guided regional anesthesia

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

1 months-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients (ASA I &#8211; II) undergoing surgery for which regional anesthesia is recommended

Key exclusion criteria

Patients with a history of diabetes mellitus, neurologic disease, or infections at the site of injection

Target sample size

2100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shinichi Sakura

Organization

Shimane University School of Medicine, University Hospital

Division name

Surgical Center

Zip code


Address

89-1, Enya-cho, Izumo City

TEL

81-853-20-2295

Email

ssakura@med.shimane-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Shinichi Sakura

Organization

Shimane University School of Medicine, University Hospital

Division name

Surgical Center

Zip code


Address

89-1, Enya-cho, Izumo City

TEL

81-853-20-2295

Homepage URL


Email

ssakura@med.shimane-u.ac.jp


Sponsor or person

Institute

Surgical Center & Department of Anesthesiology, Shimane University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

University Hospital, Shimane University School of Medicine

Organization

Division

Category of Funding Organization

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

2009 Year 07 Month 15 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

2009 Year 07 Month 15 Day

Date of IRB


Anticipated trial start date

2009 Year 07 Month 01 Day

Last follow-up date

2012 Year 06 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2009 Year 07 Month 15 Day

Last modified on

2016 Year 06 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002707


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name