UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024823
Receipt number R000025011
Scientific Title Does it enable us to administer dual-guidance (the use of ultrasound together with nerve stimulation) brachial plexus block after muscle relaxant injection by using a tourniquet on the upper limb at the induction of general anesthesia ?
Date of disclosure of the study information 2018/11/15
Last modified on 2016/11/14 13:56:31

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Basic information

Public title

Does it enable us to administer dual-guidance (the use of ultrasound together with nerve stimulation) brachial plexus block after muscle relaxant injection by using a tourniquet on the upper limb at the induction of general anesthesia ?

Acronym

Dual-guidance brachial plexus block after muscle relaxant injection.

Scientific Title

Does it enable us to administer dual-guidance (the use of ultrasound together with nerve stimulation) brachial plexus block after muscle relaxant injection by using a tourniquet on the upper limb at the induction of general anesthesia ?

Scientific Title:Acronym

Dual-guidance brachial plexus block after muscle relaxant injection.

Region

Japan


Condition

Condition

Forearm fractures

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To validate the idea of Dual-guidance brachial plexus block under administration of muscle relaxant.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Whether the use of Tourniquet on the upper limb before muscle relaxant injection can preserve forearm muscle contraction.

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

1. Put the patient to sleep with intravenous anesthetics.
2. Inflate the tourniquet on the upper limb and confirm that there is no pulse at fingertip.
3. Inject the muscle relaxant and place a endotracheal tube.
4. Brachial plexus block under Dual-guidance method
5. Assess whether the forearm muscles contract with electrical stimulation.
6. Deflate the tourniquet

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

Patients undergoing forearm osteosynthesis

ASA PS 1 - 3

Written informed consent is provided

Key exclusion criteria

Patients having allergic factors to local anesthetic

Target sample size

15


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takehisa Asahi

Organization

Joetsu General Hospital

Division name

Division of Anesthesiology

Zip code


Address

616 Daido-fukuda, Joetsu, Niigata

TEL

025-524-3000

Email

take3260@kmj.biglobe.ne.jp


Public contact

Name of contact person

1st name
Middle name
Last name Takehsia Asahi

Organization

Joetsu General Hospital

Division name

Division of Anesthesiology

Zip code


Address

616 Daido-fukuda, Joetsu, Niigata

TEL

025-524-3000

Homepage URL


Email

take3260@kmj.biglobe.ne.jp


Sponsor or person

Institute

Joetsu General Hospital

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

2018 Year 11 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

Preinitiation

Date of protocol fixation

2016 Year 03 Month 20 Day

Date of IRB


Anticipated trial start date

2016 Year 04 Month 01 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

2016 Year 11 Month 14 Day

Last modified on

2016 Year 11 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025011


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name