UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023285
Receipt number R000025650
Scientific Title Usability of heart rate variability to evaluate the PECS block in post breast cancer operative pain
Date of disclosure of the study information 2016/07/22
Last modified on 2016/07/22 14:35:46

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Basic information

Public title

Usability of heart rate variability to evaluate the PECS block in post breast cancer operative pain

Acronym

Usability of heart rate variability to evaluate the PECS block in post breast cancer operative pain

Scientific Title

Usability of heart rate variability to evaluate the PECS block in post breast cancer operative pain

Scientific Title:Acronym

Usability of heart rate variability to evaluate the PECS block in post breast cancer operative pain

Region

Japan


Condition

Condition

breast cancer

Classification by specialty

Anesthesiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

evaluation of PECS block

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Evaluation of post breast cancer operative pain with HRV in post operative few hours

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

post breast cancer patients

Key exclusion criteria

diabetes mellitus
anxiety disoder
operative massive hemorrhage
arrhythmia

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shinya Uchida

Organization

Gunma prefectural Cancer Center

Division name

anesthesiology

Zip code


Address

617-1 takabayasinisityou oota city gunma pref.

TEL

0276-38-0771

Email

s_uchida@gunma-cc.jp


Public contact

Name of contact person

1st name
Middle name
Last name Shinya Uchida

Organization

Gunma prefectural Cancer Center

Division name

anesthesiology

Zip code


Address

617-1 takabayasinisityou oota city gunma pref.

TEL

0276-38-0771

Homepage URL


Email

s_uchida@gunma-cc.jp


Sponsor or person

Institute

Gunma prefectural Cancer Center
Department of anesthesiology

Institute

Department

Personal name



Funding Source

Organization

Gunma prefectural Cancer Center
Department of anesthesiology

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



Other administrative information

Date of disclosure of the study information

2016 Year 07 Month 22 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

Completed

Date of protocol fixation

2015 Year 05 Month 28 Day

Date of IRB


Anticipated trial start date

2015 Year 06 Month 10 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

we finished this study without complications.


Management information

Registered date

2016 Year 07 Month 22 Day

Last modified on

2016 Year 07 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025650


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name