UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017875 |
|---|---|
| Receipt number | R000020706 |
| Scientific Title | Efficacy of Pectoral nerve block for perioperative pain management in breast cancer surgery |
| Date of disclosure of the study information | 2015/06/11 |
| Last modified on | 2015/06/11 12:45:37 |
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Basic information
Public title
Efficacy of Pectoral nerve block for perioperative pain management in breast cancer surgery
Acronym
Retrospective evaluation of PECS block in breast cancer surgery
Scientific Title
Efficacy of Pectoral nerve block for perioperative pain management in breast cancer surgery
Scientific Title:Acronym
Retrospective evaluation of PECS block in breast cancer surgery
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Breast surgery | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of PECS block for perioperative pain management in breast cancer surgery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Quantitiy of opioids usage during breast cancer surgery and postoperative pain during 48 hour after surgery
Key secondary outcomes
Usage of supplemental analgesics during 48 hour after surgery and incidence of PONV and other adverse events
Base
Study type
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
general anesthesia without PECS block
Interventions/Control_2
general anesthesia with PECS 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
The patients who underwent breast cancer surgery at Niigata University Medical and Dental Hospital, and did not express obvious refusa lfor the research use of the one's medical records
Key exclusion criteria
The patients who did not agree for research use of one's medical records
The patients whose medical records were incomplete
The patients who has abnormal sensation in the body trunk
The patients who already used opioids for pain control
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshinori Kamiya |
Organization
Niigata University Medical and Dental Hospital
Division name
Division of Anesthesiology
Zip code
Address
1-754 Asahimachi-dori, Chuo ward, Niigata 950-8570, Japan
TEL
025-227-2328
y-kamiya@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshinori Kamiya |
Organization
Niigata University Medical and Dental Hospital
Division name
Division of Anesthesiology
Zip code
Address
1-754 Asahimachi-dori, Chuo ward, Niigata 950-8570, Japan
TEL
025-227-2328
Homepage URL
y-kamiya@med.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University Medical and Dental Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
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 | 06 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
Partially 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
| 2014 | Year | 03 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 06 | Month | 11 | 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 | 06 | Month | 11 | Day |
Last modified on
| 2015 | Year | 06 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020706
