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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034648
Receipt No. R000039503
Scientific Title PECS 1 lock Is Effective for Motor Function Recovery in the Early Postoperative Period after Breast Cancer Surgery
Date of disclosure of the study information 2018/10/25
Last modified on 2018/10/25

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Basic information
Public title PECS 1 lock Is Effective for Motor Function Recovery in the Early Postoperative Period after Breast Cancer Surgery
Acronym PECS 1 lock Is Effective for Motor Function Recovery in the Early Postoperative Period after Breast Cancer Surgery
Scientific Title PECS 1 lock Is Effective for Motor Function Recovery in the Early Postoperative Period after Breast Cancer Surgery
Scientific Title:Acronym PECS 1 lock Is Effective for Motor Function Recovery in the Early Postoperative Period after Breast Cancer Surgery
Region
Japan

Condition
Condition Breast cancer surgery
Classification by specialty
Anesthesiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Analgesic efficacy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes number of patient, which complaint of motor function contraction in 5 day and 3 months postoperatively after Breast Cancer Surgery
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 saline
Interventions/Control_2 local anesthetic
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 Male and Female
Key inclusion criteria patients with breast cancer surgery
Key exclusion criteria patients with no breast cancer surgery
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hironobu Ueshima
Organization Showa university hospital
Division name Anesthesiology
Zip code
Address 1-5-8, hatanodai, shinagawa-ku, tokyo
TEL 03-3784-8575
Email ueshimhi@med.showa-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hironobu Ueshima
Organization Showa university hospital
Division name Anesthesiology
Zip code
Address 1-5-8, hatanodai, shinagawa-ku, tokyo
TEL 03-3784-8575
Homepage URL
Email ueshimhi@med.showa-u.ac.jp

Sponsor
Institute Showa university hospital
Institute
Department

Funding Source
Organization Showa university hospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 10 Month 25 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
2018 Year 10 Month 25 Day
Date of IRB
Anticipated trial start date
2018 Year 10 Month 25 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
2018 Year 10 Month 25 Day
Last modified on
2018 Year 10 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039503

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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