UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy of thoracic wall block for breast cancer operation -randomized double blind study-.
Acronym	Efficacy of thoracic wall block for breast cancer operation
Scientific Title	Efficacy of thoracic wall block for breast cancer operation -randomized double blind study-.
Scientific Title:Acronym	Efficacy of thoracic wall block for breast cancer operation
Region	Japan

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

Objectives
Narrative objectives1	the aim of this study is to clarify the assumption that thoracic wall block is effective for intra- and post operative pain control and suppression of postoperative nausea and vomiting.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Phase III

Assessment
Primary outcomes	intraoperative: dose of anesthetics (propofol) and opioid (remifentanil) postoperative: incidence of usage of adjuvant analgesics and spontaneous pain scale (numerical rating scale)
Key secondary outcomes	intraoperative: anesthetic induction time postopreative: incidence and degree of postoperative nausea and vomiting, incidence of adverse event and incidence and degree of persistent postoperative pain at 1,3 and 6 month after surgery

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine Maneuver
Interventions/Control_1	Thoracic wall block with 0.25% levobupivacaine was performed in the anesthesia for Thoracic wall block with 0.25% levobupivacaine was performed in the anesthesia for breast cancer sugery
Interventions/Control_2	As control, thoracic wall block with normal saline was performed in the anesthesia for Thoracic wall block with 0.25% levobupivacaine was performed in the anesthesia for breast cancer sugery
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	80 years-old >=
Gender	Female
Key inclusion criteria	The female patients who will undergo breast cancer surgery in Niigata University Hospital (from 20 y.o to 80 y.o.)
Key exclusion criteria	The patient who disagree to participate in this study ASA-physical status =/>4 The patient who has difficulty for communication (eg. patient suffered from dementia, has mental retardation, can not understand Japanese) Body Mass Index >30kg/m2 Body Weight<40kg The patient has allergy for the drugs that will use in this study Renal dysfunction or hepatic dysfunction The patient who has abnormal sensation or hypoesthesia in body trunk The patient who is received opioid medication The patient whom the examiner assume inadequate to participate in this study
Target sample size	120

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yoshinori Kamiya
Organization	Niigata University Hospital
Division name	Anesthesiology
Zip code
Address	1-757 Asahimachidori, Chuo Ward, Niigata City, Niigata Prefecture
TEL	025-227-2328
Email	y-kamiya@med.niigata-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Hiroshi Baba
Organization	Niigata University Graduate School of Medical and Dental Science
Division name	Anesthesiology
Zip code
Address	1-757 Asahimachidori, Chuo Ward, Niigata City, Niigata Prefecture
TEL	025-227-2328
Homepage URL
Email	baba@med.niigata-u.ac.jp

Sponsor
Institute	Niigata University Hospital
Institute
Department

Funding Source
Organization	Niigata University Hospital
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

Other administrative information
Date of disclosure of the study information	2014 Year 03 Month 17 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	2014 Year 03 Month 05 Day
Date of IRB	2014 Year 03 Month 20 Day
Anticipated trial start date	2014 Year 03 Month 20 Day
Last follow-up date	2017 Year 04 Month 25 Day
Date of closure to data entry
Date trial data considered complete	2017 Year 05 Month 08 Day
Date analysis concluded	2017 Year 07 Month 30 Day

Other
Other related information

Management information
Registered date	2014 Year 03 Month 17 Day
Last modified on	2021 Year 03 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015654