UMIN-CTR Clinical Trial

Basic information
Public title	The effect of Pectoral nerves block in breast cancer surgery; Randomized Controlled Trial
Acronym	The effect of Pectoral nerves block in breast cancer surgery; Randomized Controlled Trial
Scientific Title	The effect of Pectoral nerves block in breast cancer surgery; Randomized Controlled Trial
Scientific Title:Acronym	The effect of Pectoral nerves block in breast cancer surgery; Randomized Controlled Trial
Region	Japan

Condition
Condition	breast cancer
Classification by specialty	Breast surgery Anesthesiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To compare prospectively the quality of analgesia after mastectomy using general anesthesia and Pecs blocks versus general anesthesia alone.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Visual analog scale
Key secondary outcomes	Verbal Rating Scales The short-form McGill Pain Questionnaire

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	No treatment
Stratification	NO
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	US guided pectoral nerves block (pecs 1 block and pecs 2 block) preoperatively under general anesthesia
Interventions/Control_2	general anesthesia alone
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 who #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 #Inhalation anesthesia
Target sample size	44

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	0060811
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	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	none
Name of secondary funder(s)	none

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	nakahama@keijinkai.or.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	2016 Year 10 Month 03 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	2016 Year 09 Month 30 Day
Date of IRB
Anticipated trial start date	2016 Year 10 Month 06 Day
Last follow-up date	2019 Year 05 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	2016 Year 10 Month 02 Day
Last modified on	2020 Year 07 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027925

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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