UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033790 |
|---|---|
| Receipt number | R000038548 |
| Scientific Title | The comparison of the clinical effect between retrolaminar block and erector spinae plane block |
| Date of disclosure of the study information | 2018/08/17 |
| Last modified on | 2019/09/29 10:35:02 |
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Basic information
Public title
The comparison of the clinical effect between retrolaminar block and erector spinae plane block
Acronym
The comparison of the clinical effect between retrolaminar block and erector spinae plane block
Scientific Title
The comparison of the clinical effect between retrolaminar block and erector spinae plane block
Scientific Title:Acronym
The comparison of the clinical effect between retrolaminar block and erector spinae plane block
Region
| Japan |
Condition
Condition
surgical patient
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The comparison of the clinical effect between the retrolaminar block and the erector spinae plane block for the postoperative analgesia in the patients of mastectomy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The duration of the first additional analgesics after the retrolaminar block or the erector spinae plane block
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are 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
The administration of the retrolaminar block or the erector spinae plane blosk for the postoperative analgesia in the patients with mastectomy
Interventions/Control_2
the day of surgery
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
| 100 | years-old | > |
Gender
Female
Key inclusion criteria
ASA physical status I or II
Key exclusion criteria
The allergy of local analgesics, the usage of opioids in the preoperative period
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Sawada |
Organization
Sapporo Medical University, School of Medicine
Division name
Depart
Zip code
060-8543
Address
South 1 West 16, Chu-o-ku, Sapporo
TEL
0116112111
atusihon7@gmail.com
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Sawada |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Anesthesiology
Zip code
060-8543
Address
South 1 West 16, Chu-o-ku, Sapporo
TEL
0116112111
Homepage URL
atusihon7@gmail.com
Sponsor or person
Institute
Sapporo Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
JP
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sapporo Medical University School of Medicine
Address
South 1, West 16, Chuo-ku, Sapporo
Tel
0116112111
atusihon7@gmail.com
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
| 2018 | Year | 08 | 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
| 2018 | Year | 08 | Month | 15 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 14 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 17 | Day |
Last follow-up date
| 2021 | Year | 03 | 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
| 2018 | Year | 08 | Month | 17 | Day |
Last modified on
| 2019 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038548
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| Registered date | File name |
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