UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034648
Receipt number 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 2021/04/27 10:46:31

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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 Hironobu
Middle name
Last name Ueshima

Organization

Showa university hospital

Division name

Anesthesiology

Zip code

142-8666

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 Hironobu
Middle name
Last name Ueshima

Organization

Showa university hospital

Division name

Anesthesiology

Zip code

142-8666

Address

1-5-8, hatanodai, shinagawa-ku, tokyo

TEL

03-3784-8575

Homepage URL


Email

ueshimhi@med.showa-u.ac.jp


Sponsor or person

Institute

Showa university hospital

Institute

Department

Personal name



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

Showa University Hospital

Address

1-5-8, hatanodai, shinagawa-ku

Tel

03-3784-8575

Email

ueshimhi@yahoo.co.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 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

Terminated

Date of protocol fixation

2018 Year 10 Month 25 Day

Date of IRB

2018 Year 10 Month 25 Day

Anticipated trial start date

2018 Year 10 Month 25 Day

Last follow-up date

2021 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 10 Month 25 Day

Last modified on

2021 Year 04 Month 27 Day



Link to view the page

Value
https://center6.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