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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000024823
Receipt No. 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

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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
Institute Joetsu General Hospital
Institute
Department

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
URL(English) https://upload.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


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