UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034479 |
|---|---|
| Receipt number | R000039238 |
| Scientific Title | Comparison of the plasma levobupivacaine concentrations with and without epinephrine after ultrasound-guided erector spinae plane block |
| Date of disclosure of the study information | 2018/10/14 |
| Last modified on | 2022/03/09 21:14:01 |
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Basic information
Public title
Comparison of the plasma levobupivacaine concentrations with and without epinephrine after ultrasound-guided erector spinae plane block
Acronym
Comparison of the plasma levobupivacaine concentrations with and without epinephrine after ultrasound-guided erector spinae plane block
Scientific Title
Comparison of the plasma levobupivacaine concentrations with and without epinephrine after ultrasound-guided erector spinae plane block
Scientific Title:Acronym
Comparison of the plasma levobupivacaine concentrations with and without epinephrine after ultrasound-guided erector spinae plane block
Region
| Japan |
Condition
Condition
Breast surgery
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to compare the plasma levobupivacaine concentrations with and without epinephrine after ultrasound-guided erector spinae plane block.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The serum time course of the levobupivacaine concentration
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Ultrasound-guided erector spinae plane block will be performed using 2mg/kg levobupivacaine.
Interventions/Control_2
Ultrasound-guided erector spinae plane block will be performed using 2mg/kg levobupivacaine with 5microg/ml epinephrine.
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Elective breast surgery is scheduled.
2) Written informed consent for ultrasound-guided erector spinae plane block is obtained.
3) American Society of Anesthesiologists physical status is either 1, 2, or 3.
Key exclusion criteria
1) Local anesthetic allergy
2) Coagulation abnormality
3) Liver dysfunction (child-pugh score is B or C)
4) Renal dysfunction (eGFR<60)
5) Contraindication to epinephrine
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Hiroe |
| Middle name | |
| Last name | Shigeta |
Organization
National hospital organization Tokyo medical center
Division name
Anesthesiology
Zip code
152-8902
Address
2-5-1, Higashigaoka, Meguro-ku, Tokyo
TEL
03-3411-0111
hiroe_y_0614@hotmail.co.jp
Public contact
Name of contact person
| 1st name | Hiroe |
| Middle name | |
| Last name | Shigeta |
Organization
National hospital organization Tokyo medical center
Division name
Anesthesiology
Zip code
152-8902
Address
2-5-1, Higashigaoka, Meguro-ku, Tokyo
TEL
03-3411-0111
Homepage URL
hiroe_y_0614@hotmail.co.jp
Sponsor or person
Institute
National hospital organization Tokyo medical center
Institute
Department
Personal name
Funding Source
Organization
None
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
National hospital organization Tokyo medical center
Address
2-5-1, Higashigaoka, Meguro-ku, Tokyo
Tel
03-3411-0111
215-rinri@mail.hosp.go.jp
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
国立病院機構東京医療センター(東京都)
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 10 | Month | 14 | 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
34
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
| 2018 | Year | 06 | Month | 25 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 27 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 25 | Day |
Last follow-up date
| 2021 | Year | 07 | Month | 08 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 10 | Month | 13 | Day |
Last modified on
| 2022 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039238
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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