UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011610
Receipt number 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 09:46:59

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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 or person

Institute

Gifu University Hospital
Department of Anesthesiology&Pain Medicine

Institute

Department

Personal name



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

Value
https://center6.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