UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016825 |
|---|---|
| Receipt number | R000019527 |
| Scientific Title | An ultrasound-guided pecs block is effective for a breast surgery |
| Date of disclosure of the study information | 2015/03/17 |
| Last modified on | 2015/12/01 06:47:30 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
An ultrasound-guided pecs block is effective for a breast surgery
Acronym
An ultrasound-guided pecs block is effective for a breast surgery
Scientific Title
An ultrasound-guided pecs block is effective for a breast surgery
Scientific Title:Acronym
An ultrasound-guided pecs block is effective for a breast surgery
Region
| Japan |
Condition
Condition
breast tumor
Classification by specialty
| Breast surgery | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
investigation for the analgesic effect of ultrasound-guided pecs block
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
analgesia scores in postoperative
Key secondary outcomes
the dose of each analgesic drug
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Female
Key inclusion criteria
partial mastectomy
Key exclusion criteria
1. bilateral partial mastectomy
2. some cases which postoperative complications are arisen
3. some case which performed the other regional anesthesia
4. some cases which we judged it is inappropriate
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hironobu Ueshima |
Organization
Saitama Medical University International Medical Center
Division name
Anesthesiology
Zip code
Address
1397-1 Yamane, Hidaka City, Saitama, 350-1298, Japan.
TEL
042-984-4111
ueshimhi@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hironobu Ueshima |
Organization
Saitama Medical University International Medical Center
Division name
Anesthesiology
Zip code
Address
1397-1 Yamane, Hidaka City, Saitama, 350-1298, Japan.
TEL
042-984-4111
Homepage URL
ueshimhi@yahoo.co.jp
Sponsor or person
Institute
Saitama Medical University International Medical Center
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical University International Medical Center
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
Other administrative information
Date of disclosure of the study information
| 2015 | 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
| 2015 | Year | 03 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 03 | Month | 17 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observation study in 2014
Management information
Registered date
| 2015 | Year | 03 | Month | 17 | Day |
Last modified on
| 2015 | Year | 12 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019527
