UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of Pectoral nerves block in breast cancer surgery - A Retrospective Study
Title of the study (Brief title)	Pecs block in breast surgery- A 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
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	patients who undergo partial or radical mastectomy
Key exclusion criteria	patients #decline to give written informed consent, #bilateral mastectomy, #emergency or urgent case, #history of allergy to the medications used in the study, #contraindications to regional anesthesia (including coagulopathy and local infection), #undergo concomitant breast reconstruction, #dementia and psychiatric disorder
Target sample size	91

Research contact person
Name of lead principal investigator	kunio kusajima
Organization	Teine Keijinkai Hospital
Division name	Department of Anesthesiology
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	Kunio Kusajima
Organization	Teine Keijinkai Hospital
Division name	Department of Anesthesiology
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)

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	2017 Year 06 Month 26 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2017 Year 06 Month 20 Day
Anticipated trial start date	2017 Year 06 Month 27 Day
Last follow-up date	2017 Year 06 Month 30 Day
Date of closure to data entry	2017 Year 06 Month 30 Day
Date trial data considered complete	2017 Year 06 Month 30 Day
Date analysis concluded	2017 Year 07 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	We retrospectively reviewed the records of 50 patients who underwent breast surgery under PECS block combined with general anesthesia, and other 41 patients with general anesthesia alone.

Management information
Registered date	2017 Year 06 Month 26 Day
Last modified on	2019 Year 03 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031997