UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015712 |
|---|---|
| Receipt number | R000018266 |
| Scientific Title | Regional anesthesia decreases a use of anesthetic agent in breast cancer surgery and does contribute to improvement of a postoperative analgesia effect |
| Date of disclosure of the study information | 2014/11/17 |
| Last modified on | 2014/11/17 21:22:05 |
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Basic information
Public title
Regional anesthesia decreases a use of anesthetic agent in breast cancer surgery and does contribute to improvement of a postoperative analgesia effect
Acronym
Regional anesthesia decreases a use of anesthetic agent in breast cancer surgery and does contribute to improvement of a postoperative analgesia effect
Scientific Title
Regional anesthesia decreases a use of anesthetic agent in breast cancer surgery and does contribute to improvement of a postoperative analgesia effect
Scientific Title:Acronym
Regional anesthesia decreases a use of anesthetic agent in breast cancer surgery and does contribute to improvement of a postoperative analgesia effect
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Breast surgery | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To confirm the efficiency of regional anesthesia in maintenance of anesthesia during breast cancer surgery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
A use of anesthetic agent
Postoperative analgesia
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
Regional anesthesia in addition to general anesthesia for breast cancer surgery
Interventions/Control_2
General anesthesia only for breast cancer surgery
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
| Not applicable |
Gender
Female
Key inclusion criteria
patients scheduled to undergo breast cancer surgery
Key exclusion criteria
Obesity (BMI:body mass index >30kg/m2) or emaciation (BMI <18 kg/m2)
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiko Katayama |
Organization
Department of anesthesiology, Tokushima university
Division name
Anesthesiology
Zip code
Address
18-15, 3-chome, Kuramoto-cho, Tokushima-shi, Tokushima, Japan
TEL
088-633-7181
tokokata@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshiko Katayama |
Organization
Department of anesthesiology, Tokushima university
Division name
Anesthesiology
Zip code
Address
18-15, 3-chome, Kuramoto-cho, Tokushima-shi, Tokushima, Japan
TEL
088-633-7181
Homepage URL
tokokata@tokushima-u.ac.jp
Sponsor or person
Institute
Department of anesthesiology, Tokushima university
Institute
Department
Personal name
Funding Source
Organization
Department of anesthesiology, Tokushima university
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
| 2014 | Year | 11 | Month | 17 | 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
| 2014 | Year | 11 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 11 | Month | 17 | 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
| 2014 | Year | 11 | Month | 17 | Day |
Last modified on
| 2014 | Year | 11 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018266
