UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016549
Receipt number R000019208
Scientific Title Consideration of capacity and anesthesia range of ropivacaine in Serratus Plane Block
Date of disclosure of the study information 2015/02/16
Last modified on 2016/08/17 15:36:53

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Basic information

Public title

Consideration of capacity and anesthesia range of ropivacaine in Serratus Plane Block

Acronym

Consideration of capacity and anesthesia range of ropivacaine in Serratus Plane Block

Scientific Title

Consideration of capacity and anesthesia range of ropivacaine in Serratus Plane Block

Scientific Title:Acronym

Consideration of capacity and anesthesia range of ropivacaine in Serratus Plane Block

Region

Japan


Condition

Condition

Breast cancer

Classification by specialty

Breast surgery Anesthesiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To clarify the relationship between capacity and anesthesia range of ropivacaine in Serratus Plane Block

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Loss of cold and pain sensation area after the enforcement the Serratus Plane Block

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


Blinding

Double blind -all involved are blinded

Control

Dose comparison

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

The administration of 0.375% ropivacaine of 20ml in Serratus Plane Block

Interventions/Control_2

The administration of 0.375% ropivacaine of 40ml in Serratus Plane Block

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

80 years-old >

Gender

Female

Key inclusion criteria

1,ASA-PS:1 or 2
2,Breast cancer surgery

Key exclusion criteria

1,Can not be obtained the consent and cooperation
2,Allergies to use drugs
3,Weighing less than 50kg
4,BMI is 35 or more
5,Liver disease
6,Renal disease
7,Arrhythmia
8,Opioid addiction history
9,Chronic pain disease
10,Neuromuscular disease
11,Pregnant woman

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kunigou Tatsuya

Organization

Obihiro Kosei Hospital

Division name

Anesthesiology

Zip code


Address

1 west6 south8 Obihiro-shi, Hokkaido

TEL

0155-24-4161

Email

tatsuya_9250@yahoo.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kunigou Tatsuya

Organization

Obihiro Kosei Hospital

Division name

Anesthesiology

Zip code


Address

1 west6 south8 Obihiro-shi, Hokkaido

TEL

0155-24-4161

Homepage URL


Email

tatsuya_9250@yahoo.co.jp


Sponsor or person

Institute

Obihiro Kosei Hospital

Institute

Department

Personal name



Funding Source

Organization

Obihiro Kosei Hospital

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

2015 Year 02 Month 16 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

2014 Year 12 Month 18 Day

Date of IRB


Anticipated trial start date

2015 Year 02 Month 16 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 02 Month 16 Day

Last modified on

2016 Year 08 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019208


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name