UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016549 |
|---|---|
| Receipt number | R000019208 |
| Scientific Title | Consideration of capacity and anesthesia range of ropivacaine in Serratus Plane Block |
| Date of disclosure of the study information | 2015/02/16 |
| Last modified on | 2016/08/17 15:36:53 |
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Basic information
Public title
Consideration of capacity and anesthesia range of ropivacaine in Serratus Plane Block
Acronym
Consideration of capacity and anesthesia range of ropivacaine in Serratus Plane Block
Scientific Title
Consideration of capacity and anesthesia range of ropivacaine in Serratus Plane Block
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Kunigou Tatsuya |
Organization
Obihiro Kosei Hospital
Division name
Anesthesiology
Zip code
Address
1 west6 south8 Obihiro-shi, Hokkaido
TEL
0155-24-4161
tatsuya_9250@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kunigou Tatsuya |
Organization
Obihiro Kosei Hospital
Division name
Anesthesiology
Zip code
Address
1 west6 south8 Obihiro-shi, Hokkaido
TEL
0155-24-4161
Homepage URL
tatsuya_9250@yahoo.co.jp
Sponsor or person
Institute
Obihiro Kosei Hospital
Institute
Department
Personal name
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)
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
| 2015 | Year | 02 | Month | 16 | 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
Completed
Date of protocol fixation
| 2014 | Year | 12 | Month | 18 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019208
