UMIN-CTR Clinical Trial

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
Institute	Teine Keijinkai Hospital, Department of Anesthesiology
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037027