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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000026617
Receipt No. R000030569
Scientific Title Comparison of the plasma levobupivacaine concentrations after Interscalene Branchial Plexus Block and Axillary Brachial Plexus Block
Date of disclosure of the study information 2017/04/01
Last modified on 2019/04/09

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Basic information
Public title Comparison of the plasma levobupivacaine concentrations after Interscalene Branchial Plexus Block and Axillary Brachial Plexus Block
Acronym Comparison of the plasma levobupivacaine concentrations after Interscalene Branchial Plexus Block and Axillary Brachial Plexus Block
Scientific Title Comparison of the plasma levobupivacaine concentrations after Interscalene Branchial Plexus Block and Axillary Brachial Plexus Block
Scientific Title:Acronym Comparison of the plasma levobupivacaine concentrations after Interscalene Branchial Plexus Block and Axillary Brachial Plexus Block
Region
Japan

Condition
Condition surgery of the hand
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to compare the plasma levobupivacaine concentrations after ultrasound-guided Interscalene Branchial Plexus Block and Axillary Brachial Plexus Block.This study will reveal the time course of the levobupivacaine concentration.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The time course of the levobupivacaine concentration
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
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 We perform the Interscalene Branchial Plexus Block and measure plasma concentration of levobupivacaine.
Interventions/Control_2 We perform the Axillary Brachial Plexus Block and measure plasma concentration of levobupivacaine.
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
18 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 surgery of the hand and agree to Interscalene Branchial Plexus Block or Axillary Brachial Plexus Block for postoperative analgesia are enrolled in this study.
Key exclusion criteria Exclude criteria are the patients who have liver dysfunction(Child-Pugh Score>B), renal dysfunction(eGFR<60) or local anesthetic allergy.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name SAKAMOTO
Middle name
Last name NORIAKI
Organization Toho University Omori Medical Center
Division name Anesthesiology
Zip code 1438541
Address 6-11-1,Omorinishi,Ota-ku,Tokyo
TEL 03-3762-4151
Email noriaki.0909@med.toho-u.ac.jp

Public contact
Name of contact person
1st name NORIAKI
Middle name
Last name Sakamoto
Organization Toho University Omori Medical Center
Division name Anesthesiology
Zip code 1438541
Address 6-11-1,Omorinishi,Ota-ku,Tokyo
TEL 03-3762-4151
Homepage URL
Email noriaki.0909@med.toho-u.ac.jp

Sponsor
Institute Toho university
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 Toho University Omori Medical Center
Address 6-11-1,Omorinishi,Ota-ku,Tokyo
Tel 0337624151
Email Noriaki.0909@med.toho-u.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
2017 Year 04 Month 01 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 50
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 No longer recruiting
Date of protocol fixation
2017 Year 03 Month 01 Day
Date of IRB
2017 Year 02 Month 09 Day
Anticipated trial start date
2017 Year 04 Month 01 Day
Last follow-up date
2019 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 03 Month 20 Day
Last modified on
2019 Year 04 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030569

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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