UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017336
Receipt number R000020113
Scientific Title Effect of thoracic costovertebral block for extended latissimus dorsi flap breast reconstruction
Date of disclosure of the study information 2015/05/01
Last modified on 2023/11/21 12:35:22

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Basic information

Public title

Effect of thoracic costovertebral block for extended latissimus dorsi flap breast reconstruction

Acronym

Effect of thoracic costovertebral block for extended latissimus dorsi flap breast reconstruction

Scientific Title

Effect of thoracic costovertebral block for extended latissimus dorsi flap breast reconstruction

Scientific Title:Acronym

Effect of thoracic costovertebral block for extended latissimus dorsi flap breast reconstruction

Region

Japan


Condition

Condition

Breast cancer

Classification by specialty

Breast surgery Anesthesiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Verifying effect of thoracic costovertebral block for extended latissimus dorsi flap breast reconstruction

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

pain scale(visual analogue scale), area of sensory loss

Key secondary outcomes

dose of analgesics, postoperative nausea and vomiting


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

costovertebral block

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Female

Key inclusion criteria

Breast cancer patinet: scheduling extended latissimus dorsi flap in primary breast reconstruction

Key exclusion criteria

American Society of Anesthesiologists Physical Status more than 3

Target sample size

5


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tomofumi Suzuki

Organization

Keiaiakai Nakagami General Hospital

Division name

Anesthesiology

Zip code


Address

6-25-5, Chibana, Okinawa city, Okinawa Pref.

TEL

098-939-1300

Email

tomofumi-suzuki@anesth.name


Public contact

Name of contact person

1st name
Middle name
Last name Tomofumi Suzuki

Organization

Keiaikai Nakagami General Hospital

Division name

Anesthesiology

Zip code


Address

6-25-5, Chibana, Okinawa city, Okinawa Pref.

TEL

098-939-1300

Homepage URL


Email

tomofumi-suzuki@anesth.name


Sponsor or person

Institute

Anesthesiology of Nakagami General Hospital

Institute

Department

Personal name



Funding Source

Organization

none

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


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

中頭病院(沖縄県)


Other administrative information

Date of disclosure of the study information

2015 Year 05 Month 01 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

2015 Year 04 Month 30 Day

Date of IRB

2015 Year 04 Month 30 Day

Anticipated trial start date

2015 Year 05 Month 01 Day

Last follow-up date

2016 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

2015 Year 04 Month 30 Day

Last modified on

2023 Year 11 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020113


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name