UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034192
Receipt No. R000038977
Scientific Title Comparison of analgesic effect by PECS2 block after modified radical mastectomy;concentraion versus volume of levobupivacaine.
Date of disclosure of the study information 2018/09/18
Last modified on 2019/03/08

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Comparison of analgesic effect by PECS2 block after modified radical mastectomy;concentraion versus volume of levobupivacaine.
Acronym Comparison of analgesic effect by PECS2 block after modified radical mastectomy;concentraion versus volume of levobupivacaine.
Scientific Title Comparison of analgesic effect by PECS2 block after modified radical mastectomy;concentraion versus volume of levobupivacaine.
Scientific Title:Acronym 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
1st name
Middle name
Last name Hiroshi Araki
Organization National Hospital Organization Nagasaki Medical center
Division name Department of Anesthesiology
Zip code
Address 2-1001-1,Kubara,Oomura,Nagasaki
TEL 0957523121
Email haraki@nagasaki-mc.com

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Araki
Organization National Hospital Organization Nagasaki Medical center
Division name Department of Anesthesiology
Zip code
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)

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
2018 Year 09 Month 18 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 Open public recruiting
Date of protocol fixation
2018 Year 09 Month 01 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.