UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018299 |
|---|---|
| Receipt number | R000021180 |
| Scientific Title | The Combination Pectoral Nerve Block and Transversus Thoracic Muscle Plane Block is an effective analgesia for breast surgery. |
| Date of disclosure of the study information | 2015/07/16 |
| Last modified on | 2016/12/10 21:31:05 |
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Basic information
Public title
The Combination Pectoral Nerve Block and Transversus Thoracic Muscle Plane Block is an effective analgesia for breast surgery.
Acronym
The Combination Pectoral Nerve Block and Transversus Thoracic Muscle Plane Block is an effective analgesia for breast surgery.
Scientific Title
The Combination Pectoral Nerve Block and Transversus Thoracic Muscle Plane Block is an effective analgesia for breast surgery.
Scientific Title:Acronym
The Combination Pectoral Nerve Block and Transversus Thoracic Muscle Plane Block is an effective analgesia for breast surgery.
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Breast surgery | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Analgesic effect in perioperative period
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Analgesic scores after surgery
Key secondary outcomes
Analgesic doses
complidations(nausea,vomitting)
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
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
only PECS block
Interventions/Control_2
combination Pectoral Nerve Block and Transversus Thoracic Muscle 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
initial breast surgery
Key exclusion criteria
poor communication patient
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hironobu UESHIMA |
Organization
Showa University Hospital
Division name
Anesthesiology
Zip code
Address
142-8666 Hatanodai, Shinagawa-ku, Tokyo, Japan
TEL
03-3784-8875
ueshim@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hironobu UESHIMA |
Organization
Showa Universtiry Hospital
Division name
Anesthesiology
Zip code
Address
142-8666 Hatanodai, Shinagawa-ku, Tokyo, Japan
TEL
03-3784-8875
Homepage URL
ueshimhi@yahoo.co.jp
Sponsor or person
Institute
Department of Anesthesiology, Showa University Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesiology, Showa University Hospital
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 | 07 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Published
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 | 07 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 16 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 07 | Month | 14 | Day |
Last modified on
| 2016 | Year | 12 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021180
