UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Usability of heart rate variability to evaluate the PECS block in post breast cancer operative pain
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Shinya Uchida
Organization	Gunma prefectural Cancer Center
Division name	anesthesiology
Address	617-1 takabayasinisityou oota city gunma pref.
TEL	0276-38-0771
Email	s_uchida@gunma-cc.jp

Public contact
Name of contact person	Shinya Uchida
Organization	Gunma prefectural Cancer Center
Division name	anesthesiology
Address	617-1 takabayasinisityou oota city gunma pref.
TEL	0276-38-0771
Homepage URL
Email	s_uchida@gunma-cc.jp

Sponsor
Institute	Gunma prefectural Cancer Center Department of anesthesiology
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 05 Month 28 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025650