UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison of analgesic effect by PECS2 block after modified radical mastectomy;concentraion versus volume of levobupivacaine.
Title of the study (Brief title)	Comparison of analgesic effect by PECS2 block after modified radical mastectomy;concentraion versus volume of levobupivacaine.
Region	Japan

Condition
Condition	breast tumor
Classification by specialty	Breast surgery Anesthesiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to compare analgesic effect of high concentration low volume(HCLV) levobupivacaine with that of low concentration high volume(LCHV) levobupivacaine with PECS2 block. In HCLV Group,we will inject 10ml of 0.25% bupivacaine between the pectoralis major muscle(PMm) and the pectoralis minor muscle(Pmm) and 20ml will deposit at the level of the third rib above the serraths anterior muscle.In LCHV Group, We will inject 20ml of 0.125% bupivacaine between PMm and Pmm, and 40ml will deposit at the level of the third rib above the serraths anterior muscle.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	postoperative NRS after 3,6,12,24,36,48hours
Key secondary outcomes	1)the QoR(quality of Recovery)-40 on the day before surgery 2)the QoR-40 1 day after surgery 3)the QoR-40 3 days after surgery 4)consumption of intraoperative opioid 5)evaluation of nerve block area 6)the number of supplemental analgesics 7)the time of initial supplemental analgesics

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine Device,equipment Maneuver
Interventions/Control_1	We will inject 10ml of 0.25% bupivacaine between the PMm and the Pmm ,and 20ml will deposit at the level of the third rib above the serraths anterior muscle.
Interventions/Control_2	We will inject 20ml of 0.125% bupivacaine between the PMm and the Pmm ,and 40ml will deposit at the level of the third rib above the serraths anterior muscle.
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	90 years-old >=
Gender	Female
Key inclusion criteria	Patients of ASA physical status 1 or 2 schedulede for modified radical mastectomy
Key exclusion criteria	1.Patients whose body weight is less than 50kg 2.Patients who have allegy to the local anesthetics 3.Patients who did not approve participate in this study 4.Inappropriate patients for this study judged by the physicians
Target sample size	40

Research contact person
Name of lead principal investigator	Hiroshi Araki
Organization	National Hospital Organization Nagasaki Medical center
Division name	Department of Anesthesiology
Address	2-1001-1,Kubara,Oomura,Nagasaki
TEL	0957523121
Email	haraki@nagasaki-mc.com

Public contact
Name of contact person	Hiroshi Araki
Organization	National Hospital Organization Nagasaki Medical center
Division name	Department of Anesthesiology
Address	2-1001-1,Kubara,Oomura,Nagasaki
TEL	0957523121
Homepage URL
Email	haraki@nagasaki-mc.com

Sponsor
Institute	National Hospital Organization Nagasaki Medical center
Institute
Department

Funding Source
Organization	No research fund
Organization
Division
Category of Funding Organization	Other
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	2018 Year 09 Month 18 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2018 Year 09 Month 01 Day
Anticipated trial start date	2018 Year 10 Month 01 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	2018 Year 09 Month 18 Day
Last modified on	2019 Year 03 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038977