UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013435 |
|---|---|
| Receipt number | R000015654 |
| Scientific Title | Efficacy of thoracic wall block for breast cancer operation -randomized double blind study-. |
| Date of disclosure of the study information | 2014/03/17 |
| Last modified on | 2021/03/22 22:34:20 |
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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
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
baba@med.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015654
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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