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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011610
Receipt No. R000013583
Scientific Title Efficacy of continuous paravertebral blocks in breast surgery
Date of disclosure of the study information 2013/08/31
Last modified on 2021/03/08

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Basic information
Public title Efficacy of continuous paravertebral blocks in breast surgery
Acronym Efficacy of continuous paravertebral blocks in breast surgery
Scientific Title Efficacy of continuous paravertebral blocks in breast surgery
Scientific Title:Acronym Efficacy of continuous paravertebral blocks in breast surgery
Region
Japan

Condition
Condition breast cancer
Classification by specialty
Breast surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the efficacy of continuous paravertebral blocks with general anesthesia in breast surgery:the expanse of contrast media,the need for anesthetics and analgesics,PONV
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes VAS(VIsual Analogue Scale),rescue analgesics,PONV(post operative nausea and vomiting),nerve damage,failed anaesthetics technique
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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 Female
Key inclusion criteria breast cancer surgery
ASA physical status 1-3
20 years old or older
agreed to participate in the study and signed informed consent form
Key exclusion criteria Patients with severe cerebra-vascular disease or coronary heart disease
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Yuko
Middle name
Last name Yamada
Organization Gifu University Hospital
Division name Department of Anesthesiology&Pain Medicine
Zip code 5011194
Address 1-1 Yanagido, Gifu City, Gifu
TEL 058-230-6404
Email y-comet@wg7.so-net.ne.jp

Public contact
Name of contact person
1st name Yuko
Middle name
Last name Yamada
Organization Gifu University Hospital
Division name Department of Anesthesiology&Pain Medicine
Zip code 5011194
Address 1-1 Yanagido, Gifu City, Gifu
TEL 058-230-6404
Homepage URL
Email y-comet@wg7.so-net.ne.jp

Sponsor
Institute Gifu University Hospital
Department of Anesthesiology&Pain 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 Gifu University
Address 1-1 Yanagido, Gifu City, Gifu
Tel 058-230-1111
Email y-comet@wg7.so-net.ne.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
2013 Year 08 Month 31 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 60
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
2013 Year 05 Month 22 Day
Date of IRB
2013 Year 06 Month 05 Day
Anticipated trial start date
2013 Year 06 Month 05 Day
Last follow-up date
2021 Year 03 Month 08 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We assess the expanse of contrast media of paravertebral block, the need for anesthetics and analgesia during operation , post-operative analgesia(VAS;Visual Analogue Scale,the need for rescue analgesia) and side effects(numbness, nausea, vomiting) in breast surgery with general anesthesia.

Management information
Registered date
2013 Year 08 Month 31 Day
Last modified on
2021 Year 03 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013583

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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