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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041214
Receipt No. R000047069
Scientific Title Comparison of 0.25% levobupivacaine 10 ml or 0.125% levobupivacaine 10 ml for Interscalene Brachial Plexus Block for analgesic effect and motor function
Date of disclosure of the study information 2020/07/27
Last modified on 2020/07/27

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Basic information
Public title Comparison of 0.25% levobupivacaine 10 ml or 0.125% levobupivacaine 10 ml for Interscalene Brachial Plexus Block for analgesic effect and motor function
Acronym Comparison of 0.25% levobupivacaine 10 ml or 0.125% levobupivacaine 10 ml for Interscalene Brachial Plexus Block for analgesic effect and motor function
Scientific Title Comparison of 0.25% levobupivacaine 10 ml or 0.125% levobupivacaine 10 ml for Interscalene Brachial Plexus Block for analgesic effect and motor function
Scientific Title:Acronym Comparison of 0.25% levobupivacaine 10 ml or 0.125% levobupivacaine 10 ml for Interscalene Brachial Plexus Block for analgesic effect and motor function
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the analgesic effect and motor function of 0.25% levobupivacaine 10 ml or 0.125% levobupivacaine 10 ml for Interscalene Brachial Plexus Block.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Motor function and pain within 1 hour after surgery and analgesic duration
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 In surgery of the shoulder or upper arm, brachial plexus block is performed by the interscalene method after induction of anesthesia. At that time, 10 ml of 0.25% levobupivacaine is used as the drug.
Interventions/Control_2 In surgery of the shoulder or upper arm, brachial plexus block is performed by the interscalene method after induction of anesthesia. At that time, 10 ml of 0.125% levobupivacaine is used as the drug.
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 scheduled for surgery on shoulder or upper arm
Key exclusion criteria Patients who are taking antipsychotics, patients with mental illness, severe obesity (BMI 35 or higher), patients with chronic pain, patients who are taking opioids and analgesics, patients with dementia, and those who refuse to participate.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Hayato
Middle name
Last name Terashima
Organization National Defense Medical College
Division name Department of Anesthesiology
Zip code 359-0513
Address 3-2 Namiki Tokorozawa Sitama
TEL 04-2995-1211
Email doc33043@ndmc.ac.jp

Public contact
Name of contact person
1st name Hayato
Middle name
Last name Terashima
Organization National Defense Medical College
Division name Department of Anesthesiology
Zip code 359-0513
Address 3-2 Namiki Tokorozawa Sitama
TEL 04-2995-1211
Homepage URL
Email doc33043@ndmc.ac.jp

Sponsor
Institute National Defense Medical College
Institute
Department

Funding Source
Organization National Defense Medical College
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization National Defense Medical College
Address 3-2 Namiki Tokorozawa Sitama
Tel 04-2995-1211
Email doc33043@ndmc.ac.jp

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
2020 Year 07 Month 27 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
2020 Year 07 Month 27 Day
Date of IRB
Anticipated trial start date
2020 Year 07 Month 27 Day
Last follow-up date
2022 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
2020 Year 07 Month 27 Day
Last modified on
2020 Year 07 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047069

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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