UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027933 |
|---|---|
| Receipt number | R000031997 |
| Scientific Title | The effect of Pectoral nerves block in breast cancer surgery - A Retrospective Study |
| Date of disclosure of the study information | 2017/06/26 |
| Last modified on | 2019/03/03 14:09:59 |
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Basic information
Public title
The effect of Pectoral nerves block in breast cancer surgery - A Retrospective Study
Acronym
Pecs block in breast surgery- A Retrospective Study
Scientific Title
The effect of Pectoral nerves block in breast cancer surgery - A Retrospective Study
Scientific Title:Acronym
Pecs block in breast surgery- A Retrospective Study
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Breast surgery | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare the quality of analgesia after mastectomy using general anesthesia with Pecs blocks versus general anesthesia alone retrospectively.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Verbal Rating Scale of pain (VRS: 1; none, 2; mild, 3; moderate, 4; severe) at postoperative 1 and 24 hours.
Key secondary outcomes
The interval between the end of the operation and the first rescue analgesia
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| 99 | years-old | >= |
Gender
Female
Key inclusion criteria
patients who undergo partial or radical mastectomy
Key exclusion criteria
patients
#decline to give written informed consent,
#bilateral mastectomy,
#emergency or urgent case,
#history of allergy to the medications used in the study,
#contraindications to regional anesthesia (including coagulopathy and local infection),
#undergo concomitant breast reconstruction,
#dementia and psychiatric disorder
Target sample size
91
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | kunio kusajima |
Organization
Teine Keijinkai Hospital
Division name
Department of Anesthesiology
Zip code
Address
1-40, 1-jo 12-chome, Maeda, Teine-ku, Sapporo, Hokkaido, Japan.
TEL
011-681-8111
kunio555@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kunio Kusajima |
Organization
Teine Keijinkai Hospital
Division name
Department of Anesthesiology
Zip code
Address
1-40, 1-jo 12-chome, Maeda, Teine-ku, Sapporo, Hokkaido, Japan.
TEL
011-681-8111
Homepage URL
kunio555@gmail.com
Sponsor or person
Institute
Teine Keijinkai Hospital, Department of Anesthesiology
Institute
Department
Personal name
Funding Source
Organization
Teine Keijinkai Hospital, Department of Anesthesiology
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 06 | Month | 26 | 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
| 2017 | Year | 06 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 06 | Month | 27 | Day |
Last follow-up date
| 2017 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2017 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2017 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2017 | Year | 07 | Month | 01 | Day |
Other
Other related information
We retrospectively reviewed the records of 50 patients who underwent breast surgery under PECS block combined with general anesthesia, and other 41 patients with general anesthesia alone.
Management information
Registered date
| 2017 | Year | 06 | Month | 26 | Day |
Last modified on
| 2019 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031997
