UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016671 |
|---|---|
| Receipt number | R000019349 |
| Scientific Title | The effectiveness of the ultrasound-guided thoracic wall nerve blocks to the breast surgery. |
| Date of disclosure of the study information | 2015/05/01 |
| Last modified on | 2018/12/11 09:38:28 |
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Basic information
Public title
The effectiveness of the ultrasound-guided thoracic wall nerve blocks to the breast surgery.
Acronym
The effectiveness of the ultrasound-guided thoracic wall nerve blocks to the breast surgery.
Scientific Title
The effectiveness of the ultrasound-guided thoracic wall nerve blocks to the breast surgery.
Scientific Title:Acronym
The effectiveness of the ultrasound-guided thoracic wall nerve blocks to the breast surgery.
Region
| Japan |
Condition
Condition
Elective mastectomy for breast cancer
Classification by specialty
| Breast surgery | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In this study I consider the effectiveness of acute pain and chronic pain of breast cancer after surgery due to Thoracic wall nerve block (PECS2 block and serratus plane block).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Chronic pain after 6 months
(use NRS;Numeric Rating Scale)
Key secondary outcomes
Chronic pain after 2 months
(use NRS;Numeric Rating Scale)
Acute pain after 24 hours
(use VAS;Visual Analog Scale)
Dose of postoperative morphine
Health Related Quality of Life after 2 months and 6 months (use EuroQol-5D)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
PECS2 block
Interventions/Control_2
Serratus plane block
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
Elective mastectomy for breast cancer
American Society of Anesthesiologists Physical Status Classification 1-2
Preoperative ADL is independence
Written informed consent is provided
Key exclusion criteria
Consciousness disabilities
Enough judgment ability nothing
Male
Emergency
ASA-PS over 3
History of hypersensitivity to ropivacaine or amide type local anesthetic
Hemodialysis
Renal dysfunction (less than eGFR30)
Liver dysfunction (Child-Pugh classification more B)
Blood clotting disorder (less than 100,000 platelets/mcl, PT-INR 1.5 or more, less than APTT% 70%)
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kimitoshi Nishiwaki |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Anesthesiology
Zip code
Address
65 Tsuruna-cho, Showa-ku, Nagoya, 466-8550 Japan
TEL
052-744-2340
nishi@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tasuku Fujii |
Organization
Nagoya University Hospital
Division name
Department of Anesthesiology
Zip code
Address
65 Tsuruna-cho, Showa-ku, Nagoya, 466-8550 Japan
TEL
052-744-2340
Homepage URL
plus9@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine, Biomedical Regulation, Department of Anesthesiology
Institute
Department
Personal name
Funding Source
Organization
Nagoya University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Other
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
名古屋大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 05 | Month | 01 | 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
| 2015 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 03 | Month | 01 | Day |
Last modified on
| 2018 | Year | 12 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019349
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
