UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017338 |
|---|---|
| Receipt number | R000020116 |
| Scientific Title | Effect of pectoral nerve block for extended latissimus dorsi flap breast reconstruction |
| Date of disclosure of the study information | 2015/05/01 |
| Last modified on | 2016/03/07 15:58:52 |
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Basic information
Public title
Effect of pectoral nerve block for extended latissimus dorsi flap breast reconstruction
Acronym
Effect of pectoral nerve block for extended latissimus dorsi flap breast reconstruction
Scientific Title
Effect of pectoral nerve block for extended latissimus dorsi flap breast reconstruction
Scientific Title:Acronym
Effect of pectoral nerve block for extended latissimus dorsi flap breast reconstruction
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Breast surgery | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Verifying effect of pectral nerve block and serratus plane block for extended latissimus dorsi flap breast reconstruction
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
pain scale(visual analogue scale), area of sensory loss
Key secondary outcomes
dose of analgesics, postoperative nausea and vomiting
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
PECS1 block and serratus plane block
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
| Not applicable |
Gender
Female
Key inclusion criteria
Breast cancer patinet: scheduling extended latissimus dorsi flap in primary breast reconstruction
Key exclusion criteria
American Society of Anesthesiologists Physical Status more than 3
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomofumi Suzuki |
Organization
Keiaiakai Nakagami General Hospital
Division name
Anesthesiology
Zip code
Address
6-25-5, Chibana, Okinawa city, Okinawa Pref.
TEL
098-939-1300
tomofumi-suzuki@anesth.name
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomofumi Suzuki |
Organization
Keiaikai Nakagami General Hospital
Division name
Anesthesiology
Zip code
Address
6-25-5, Chibana, Okinawa city, Okinawa Pref.
TEL
098-939-1300
Homepage URL
tomofumi-suzuki@anesth.name
Sponsor or person
Institute
Anesthesiology of Nakagami General Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
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
中頭病院（沖縄県）
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
Terminated
Date of protocol fixation
| 2015 | Year | 04 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 04 | Month | 30 | Day |
Last modified on
| 2016 | Year | 03 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020116
