UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039700 |
|---|---|
| Receipt number | R000044581 |
| Scientific Title | Randomized, single-blind,parallel clinical trial on analgesic efficacy of ESP block versus TPV block in patients undergoing tissue expander breast reconstruction |
| Date of disclosure of the study information | 2020/03/04 |
| Last modified on | 2024/07/31 22:12:20 |
* 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
Evaluation of analgesic efficacy of ESP block versus TPV block in patients undergoing tissue expander breast reconstruction
Acronym
Evaluation of analgesic efficacy of ESP block versus TPV block in patients undergoing tissue expander breast reconstruction
Scientific Title
Randomized, single-blind,parallel clinical trial on analgesic efficacy of ESP block versus TPV block in patients undergoing tissue expander breast reconstruction
Scientific Title:Acronym
trial on analgesic efficacy of ESP block versus TPV block in patients undergoing tissue expander breast reconstruction
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Breast surgery | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The comparison of the clinical effect between the erector spinae plane block and thorcic paravertebral block for the postoperative analgesia in the patients of breast reconstruction surgery with tissue expander
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
postoperative visual analogue scale
Key secondary outcomes
complication
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
YES
Institution consideration
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
The administration of the erector spinae plane block for the postoperative analgesia in the patients scheduled for breast reconstruction surgery with tissue expander
Interventions/Control_2
The administration of the thoracic paravertebral block for the postoperative analgesia in the patients scheduled for breast reconstruction surgery with tissue expander
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
| 70 | years-old | >= |
Gender
Female
Key inclusion criteria
ASA physical status classification I-II
Key exclusion criteria
Patients who receive regurally analgesics within preoperative one month
Patients with dementia
Patients with thrombocytopenia or coagulopathy
Patients undergoing antiplatelet or anticogulant therapy
Patients with allergy to ropivacaine
Patients who are pregnant or nursing
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yasuo |
| Middle name | |
| Last name | Tsutsumi |
Organization
Hiroshima University Hospital
Division name
anesthesiology
Zip code
7348551
Address
1-2-3, Kasumi, Minami-ku, Hiroshima
TEL
0822575267
oshitak@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Kyoko |
| Middle name | |
| Last name | Oshita |
Organization
Hiroshima University Hospital
Division name
anesthesiology
Zip code
7348551
Address
1-2-3, Kasumi, Minami-ku, Hiroshima
TEL
0822575267
Homepage URL
oshitak@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University Hospital
Department of Anesthesiology
Institute
Department
Personal name
Funding Source
Organization
Hiroshima University Hospital
Department of Anesthesiology
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee for Clinical Research of Hiroshima University
Address
1-2-3, Kasumi, Minami-ku, Hiroshima
Tel
0822571947
iryo-seisaku@office.hiroshima-u.ac.jp
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
広島大学病院（広島県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 03 | Month | 04 | 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
| 2020 | Year | 03 | Month | 02 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 02 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 05 | Day |
Last follow-up date
| 2022 | Year | 10 | 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
| 2020 | Year | 03 | Month | 04 | Day |
Last modified on
| 2024 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044581
