UMIN-CTR Clinical Trial

Basic information
Public title	The efficacy and safety of peripheral nerve block: a randomized controlled study
Acronym	The efficacy and safety of peripheral nerve block: a randomized controlled study
Scientific Title	The efficacy and safety of peripheral nerve block: a randomized controlled study
Scientific Title:Acronym	The efficacy and safety of peripheral nerve block: a randomized controlled study
Region	Japan

Condition
Condition	Case to undergo mastectomy for malignant breast tumor with/without axillary lymphadenectomy
Classification by specialty	Breast surgery Anesthesiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Assess the arterial local anesthetic concentrations and efficacy of continuous paravertebral block lamina approach in patients after mastectomy.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Arterial local anesthetic concentrations
Key secondary outcomes	Pain score Elapsed time until first additional analgesia after surgery

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Dose comparison
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms	4
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Bolus: 0.375% levobupivacaine 20mL Continuous: 0.25% levobupivacaine 4mL/hr
Interventions/Control_2	bolus 0.75% levobupivacaine 10mL Continuous: 0.25% levobupivacaine 4mL/hr
Interventions/Control_3	Bolus: 0.25% levobupivacaine 20mL Continuous: 0.25% levobupivacaine 4mL/hr
Interventions/Control_4	Bolus: saline 20mL Continuous: 0.25% levobupivacaine 4mL/hr
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	Female
Key inclusion criteria	Patients (American Society of Anesthesiologists physical status I-III) scheduled for elective mastectomy with/without axillary lymphadenectomy for malignant breast tumor
Key exclusion criteria	Patients were excluded if they were younger than 18 years or older than 80 years of age, had a history of allergy to local anesthetics, had a history of neurological disorder affecting the corresponding limb, using opioid or analgesic regularly for chronic pain, or were pregnant.
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Middle name Last name Michiaki Yamakage
Organization	Sapporo Medical University School of Medicine
Division name	Department of Anesthesiology
Zip code
Address	South 1 West 16 Chuo-ku, Sapporo, Hokkaido 060-8556, Japan
TEL	011-611-2111(ext.3568)
Email	yamakage@sapmed.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Takeshi Murouchi
Organization	Sapporo Medical University School of Medicine
Division name	Department of Anesthesiology
Zip code
Address	South 1 West 16 Chuo-ku, Sapporo, Hokkaido 060-8556, Japan
TEL	011-611-2111(ext.3568)
Homepage URL
Email	murouchi@sapmed.ac.jp

Sponsor
Institute	Sapporo Medical University School of Medicine
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	札幌医科大学附属病院（北海道）

Other administrative information
Date of disclosure of the study information	2015 Year 05 Month 27 Day

Related information
URL releasing protocol
Publication of results	Published

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	Completed
Date of protocol fixation	2015 Year 05 Month 15 Day
Date of IRB
Anticipated trial start date	2015 Year 05 Month 28 Day
Last follow-up date	2017 Year 12 Month 31 Day
Date of closure to data entry	2018 Year 01 Month 31 Day
Date trial data considered complete	2018 Year 01 Month 31 Day
Date analysis concluded	2018 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2015 Year 05 Month 27 Day
Last modified on	2016 Year 10 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020504

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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