UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032472
Receipt number R000037027
Scientific Title The effect of Pectoral nerves block in breast cancer surgery -Retrospective Study
Date of disclosure of the study information 2018/05/05
Last modified on 2021/12/06 06:13:21

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Basic information

Public title

The effect of Pectoral nerves block in breast cancer surgery -Retrospective Study

Acronym

Pecs block in breast cancer surgery- Retrospective Study

Scientific Title

The effect of Pectoral nerves block in breast cancer surgery -Retrospective Study

Scientific Title:Acronym

Pecs block in breast cancer surgery- Retrospective Study

Region

Japan


Condition

Condition

breast cancer

Classification by specialty

Breast surgery Anesthesiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To compare the quality of analgesia after mastectomy using general anesthesia with Pecs blocks versus general anesthesia alone retrospectively.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Verbal Rating Scale of pain (VRS: 1; none, 2; mild, 3; moderate, 4; severe) at postoperative 1 and 24 hours.

Key secondary outcomes

The interval between the end of the operation and the first rescue analgesia


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


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

18 years-old <=

Age-upper limit

99 years-old >

Gender

Female

Key inclusion criteria

patient who undergo partial or radical mastectomy for breast cancer

Key exclusion criteria

bilateral mastectomy
simultaneous breast reconstruction
concomitant operation for other organ
other nerve block administration

Target sample size

198


Research contact person

Name of lead principal investigator

1st name Kunio
Middle name
Last name Kusajima

Organization

Teine Keijinkai Hospital

Division name

Department of Anesthesiology

Zip code

006-0811

Address

1-40, 1-jo 12-chome, Maeda, Teine-ku, Sapporo, Hokkaido, Japan.

TEL

011-681-8111

Email

kunio555@gmail.com


Public contact

Name of contact person

1st name Kunio
Middle name
Last name Kusajima

Organization

Teine Keijinkai Hospital

Division name

Department of Anesthesiology

Zip code

0060811

Address

1-40, 1-jo 12-chome, Maeda, Teine-ku, Sapporo, Hokkaido, Japan.

TEL

011-681-8111

Homepage URL


Email

kunio555@gmail.com


Sponsor or person

Institute

Teine Keijinkai Hospital, Department of Anesthesiology

Institute

Department

Personal name



Funding Source

Organization

Teine Keijinkai Hospital, Department of Anesthesiology

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

Teine Keijinkai Hospital

Address

1-40, 1-jo 12-chome, Maeda, Teine-ku, Sapporo, Hokkaido, Japan.

Tel

011-681-8111

Email

kunio555@gmail.com


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 05 Month 05 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

Completed

Date of protocol fixation

2018 Year 04 Month 17 Day

Date of IRB

2018 Year 04 Month 17 Day

Anticipated trial start date

2018 Year 05 Month 07 Day

Last follow-up date

2019 Year 02 Month 01 Day

Date of closure to data entry

2019 Year 02 Month 15 Day

Date trial data considered complete

2019 Year 03 Month 01 Day

Date analysis concluded

2019 Year 12 Month 01 Day


Other

Other related information

none


Management information

Registered date

2018 Year 05 Month 05 Day

Last modified on

2021 Year 12 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037027


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name