UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000034192 |
|---|---|
| Receipt number | 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 01:51:04 |
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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
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
haraki@nagasaki-mc.com
Sponsor or person
Institute
National Hospital Organization Nagasaki Medical center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038977
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