UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043549
Receipt number R000049694
Scientific Title Effect of combined PECS1 block with serratus plane block for postoperative pain after total mastectomy
Date of disclosure of the study information 2021/03/15
Last modified on 2023/03/11 10:28:43

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Basic information

Public title

Effect of combined pectoral nerve block(PECS)1 block with serratus plane block for postoperative pain after total mastectomy

Acronym

Effect of combined pectoral nerve block(PECS)1 block with serratus plane block for postoperative pain after total mastectomy

Scientific Title

Effect of combined PECS1 block with serratus plane block for postoperative pain after total mastectomy

Scientific Title:Acronym

Effect of combined PECS1 block with serratus plane block for postoperative pain after total mastectomy

Region

Japan


Condition

Condition

post-mastectomy pain syndrome

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to evaluate the efficacy of combined PECS1 and seratus plane blocks for postoperative breast pain.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

NRS at rest 6 months after surgery

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

0.375% Ropivacaine(10ml) will be administered for PECS1 block prior to mastectomy after induction of general anesthesia.

Interventions/Control_2

Normal saline(10ml) will be administered for PECS1 block prior to mastectomy after induction of general anesthesia.

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

Adult women with ASA-PS 1 or 2 undergoing unilateral total mastectomy.
This includes cases in which sentinel lymph node resection or axillary lymph node dissection is performed.

Key exclusion criteria

Simultaneous bilateral surgery, insertion of breast expanders and implants, endoscopic surgery, history of breast surgery, allergy to target drugs, asthma, psychiatric disorders, hepatic, renal, and coagulation dysfunction

Target sample size

100


Research contact person

Name of lead principal investigator

1st name kono
Middle name
Last name hiroyuki

Organization

kameda medical center

Division name

Department of Anesthesiology

Zip code

296-8602

Address

929 Higashi-machi, Kamogawa-shi, Chiba

TEL

04-7092-2211

Email

kono.hiroyuki@kameda.jp


Public contact

Name of contact person

1st name kono
Middle name
Last name hiroyuki

Organization

kameda medical center

Division name

Department of Anesthesiology

Zip code

296-8602

Address

929 Higashi-machi, Kamogawa-shi, Chiba

TEL

04-7092-2211

Homepage URL


Email

kono.hiroyuki@kameda.jp


Sponsor or person

Institute

kameda medical center

Institute

Department

Personal name



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

kameda medical center

Address

929 Higashi-machi, Kamogawa-shi, Chiba

Tel

04-7092-2211

Email

clinical_research@kameda.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

2021 Year 03 Month 15 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

2021 Year 02 Month 24 Day

Date of IRB

2021 Year 02 Month 24 Day

Anticipated trial start date

2021 Year 05 Month 11 Day

Last follow-up date

2023 Year 08 Month 31 Day

Date of closure to data entry

2023 Year 08 Month 31 Day

Date trial data considered complete

2023 Year 08 Month 31 Day

Date analysis concluded

2023 Year 08 Month 31 Day


Other

Other related information



Management information

Registered date

2021 Year 03 Month 08 Day

Last modified on

2023 Year 03 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049694


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name