UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Consideration of capacity and anesthesia range of ropivacaine in Serratus Plane Block
Title of the study (Brief title)	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	Kunigou Tatsuya
Organization	Obihiro Kosei Hospital
Division name	Anesthesiology
Address	1 west6 south8 Obihiro-shi, Hokkaido
TEL	0155-24-4161
Email	tatsuya_9250@yahoo.co.jp

Public contact
Name of contact person	Kunigou Tatsuya
Organization	Obihiro Kosei Hospital
Division name	Anesthesiology
Address	1 west6 south8 Obihiro-shi, Hokkaido
TEL	0155-24-4161
Homepage URL
Email	tatsuya_9250@yahoo.co.jp

Sponsor
Institute	Obihiro Kosei Hospital
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 12 Month 18 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019208