UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024253 |
|---|---|
| Receipt number | R000027925 |
| Scientific Title | The effect of Pectoral nerves block in breast cancer surgery; Randomized Controlled Trial |
| Date of disclosure of the study information | 2016/10/03 |
| Last modified on | 2021/12/06 06:11:24 |
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Basic information
Public title
The effect of Pectoral nerves block in breast cancer surgery; Randomized Controlled Trial
Acronym
The effect of Pectoral nerves block in breast cancer surgery; Randomized Controlled Trial
Scientific Title
The effect of Pectoral nerves block in breast cancer surgery; Randomized Controlled Trial
Scientific Title:Acronym
The effect of Pectoral nerves block in breast cancer surgery; Randomized Controlled Trial
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Breast surgery | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare prospectively the quality of analgesia after mastectomy using general anesthesia and Pecs blocks versus general anesthesia alone.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Visual analog scale
Key secondary outcomes
Verbal Rating Scales
The short-form McGill Pain Questionnaire
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
US guided pectoral nerves block (pecs 1 block and pecs 2 block) preoperatively under general anesthesia
Interventions/Control_2
general anesthesia alone
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 who
#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
#Inhalation anesthesia
Target sample size
44
Research contact person
Name of lead principal investigator
| 1st name | Kunio |
| Middle name | |
| Last name | Kusajima |
Organization
Teine Keijinkai Hospital
Division name
Department of Anesthesiology
Zip code
0060811
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 | Kunio |
| Middle name | |
| Last name | Kusajima |
Organization
Teine Keijinkai Hospital
Division name
Department of Anesthesiology
Zip code
0060811
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
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
none
Name of secondary funder(s)
none
IRB Contact (For public release)
Organization
Teine Keijinkai Hospital
Address
1-40, 1-jo 12-chome, Maeda, Teine-ku, Sapporo, Hokkaido, Japan.
Tel
011-681-8111
nakahama@keijinkai.or.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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 10 | Month | 03 | 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
| 2016 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 06 | Day |
Last follow-up date
| 2019 | Year | 05 | 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
| 2016 | Year | 10 | Month | 02 | Day |
Last modified on
| 2021 | Year | 12 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027925
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
