UMIN-CTR Clinical Trial

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