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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000031746
Receipt No. 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 2019/09/15

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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
Email 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
Email kumiko-t@m2.gao.ne.jp

Sponsor
Institute Gifu University Graduate of School of Medicine
Institute
Department

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
Email 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
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 No longer recruiting
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
2022 Year 03 Month 31 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 09 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031234

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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