UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031746 |
|---|---|
| Receipt number | R000031234 |
| Scientific Title | Differential effect of postoperative analgesics after mastectomy with reconstruction |
| Date of disclosure of the study information | 2018/03/16 |
| Last modified on | 2019/11/12 15:59:12 |
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Basic information
Public title
Differential effect of postoperative analgesics after mastectomy with reconstruction
Acronym
analgesia after breast cancer
Scientific Title
Differential effect of postoperative analgesics after mastectomy with reconstruction
Scientific Title:Acronym
analgesia after breast cancer
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Impact of analgesics on shoulder movement after breast cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
after cancellation of shoulder joint movement restriction: measurement of shoulder joint motion range
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
postoperative medication: selecoxib
Interventions/Control_2
postoperative medication : tramadol
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 who undergo mastectomy and reconstruction with tissue expander for beast cancer
Key exclusion criteria
bilateral breast cancer
unable communication
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kumiko |
| Middle name | |
| Last name | Tanabe |
Organization
Gifu University Graduate of School of Medicine
Division name
Anesthesiology and Pain Medicine
Zip code
501-1194
Address
Gifu City, Yanagido 1-1
TEL
058-230-6404
kumiko-t@m2.gao.ne.jp
Public contact
Name of contact person
| 1st name | Kumiko |
| Middle name | |
| Last name | Tanabe |
Organization
Gifu University Graduate of School of Medicine
Division name
Anesthesiology and Pain Medicine
Zip code
501-1194
Address
Gifu City, Yanagido 1-1
TEL
058-230-6404
Homepage URL
kumiko-t@m2.gao.ne.jp
Sponsor or person
Institute
Gifu University Graduate of School of Medicine
Institute
Department
Personal name
Funding Source
Organization
self-funding
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
Gifu University Graduate Scholl of Medicine
Address
Yanagido 1-1, Gifu City
Tel
058-230-6404
kumiko-t@m2.gyao.ne.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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 03 | 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
23
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
| 2017 | Year | 06 | Month | 07 | Day |
Date of IRB
| 2017 | Year | 06 | Month | 07 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 07 | Day |
Last follow-up date
| 2019 | Year | 11 | Month | 12 | 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 | 03 | Month | 15 | Day |
Last modified on
| 2019 | Year | 11 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031234
