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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017691
Receipt No. R000020504
Scientific Title The efficacy and safety of peripheral nerve block: a randomized controlled study
Date of disclosure of the study information 2015/05/27
Last modified on 2016/10/10

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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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