UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016521 |
|---|---|
| Receipt number | R000019184 |
| Scientific Title | Effecs of Pectoral major plane block in breast cancer patients treated with partial mastectomy and sentinel node biopsy: comparison of postoperative pain with or without the block, Randomized Controlled Trial |
| Date of disclosure of the study information | 2015/02/12 |
| Last modified on | 2016/03/25 08:47:00 |
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Basic information
Public title
Effecs of Pectoral major plane block in breast cancer patients treated with partial mastectomy and sentinel node biopsy: comparison of postoperative pain with or without the block, Randomized Controlled Trial
Acronym
Effecs of Pectoral major plane block in breast cancer patients treated with partial mastectomy and sentinel node biopsy: comparison of postoperative pain with or without the block, Randomized Controlled Trial
Scientific Title
Effecs of Pectoral major plane block in breast cancer patients treated with partial mastectomy and sentinel node biopsy: comparison of postoperative pain with or without the block, Randomized Controlled Trial
Scientific Title:Acronym
Effecs of Pectoral major plane block in breast cancer patients treated with partial mastectomy and sentinel node biopsy: comparison of postoperative pain with or without the block, Randomized Controlled Trial
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Surgery in general | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The pectoral nerves block type 1 and 2 are novel approach to block the pectoral, intercostobrachial, 3rd to 6th intercostals, and the long thoracic nerves. But the effect of nerves block is insufficient of parasternal area, close to nipple. The anterior branches of the intercostal nerves innervates the inner aspects of pectoralis major muscles (PMm). The aim to block the anterior branches of the intercostal nerves, local anesthetic is deposited to the plane of PMm (PMPB).
Our study prospectively compares the effect of analgesia in and after partial mastectomy with sentinel lymphadenectomy using US guided Pecs block undesr general anesthesia versus PMPB with Pecs block under general anesthesia.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) NRS
2) SF-MPQ2
Key secondary outcomes
1) Consumption of intraoperative analgesic agent
2) Consumption of postoperative analgesic agent
3) Severity of PONV using a Likert scale (none, mild, moderate, and severe)
Base
Study type
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
US guided pectoral nerves block (pecs 1 block and pecs 2 block) and PMPB (pectoral major muscle plane block ) preoperatively under general anesthesia.
Interventions/Control_2
US guided pectoral nerves block (pecs 1 block and pecs 2 block) preoperatively under general anesthesia.
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
1. America Society of Anesthesiologist physical status (ASA-PS) 1-2
2.Brest cancer patients scheduled to partial mastectomy with sentinel lymphadenectomy under general anesthesia
3. Age>=20
4. Written informed consent
Key exclusion criteria
1. Declinin to give informed consent
2. Body mass index (BMI) >=35/kg/m2
3. History of allergy to the medications used in the study
4. Contraindication to regional anesthesia (including coagulopathy and local infection)
5. Prior breast surgery except for diagnostic biopsies
6. History of treatment for a chronic pain condition and/or psychiatric disorder
7. Considered ineligible
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sayaka Masuda |
Organization
Tokyo Metropolitan Ohtsuka Hospital
Division name
Department of Anesthesiology
Zip code
Address
2-8-1, Minamiohtsuka, Toshima-ku, Tokyo
TEL
03+3941+3211(6098)
mistysky_aaa@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sayaka Masuda |
Organization
Tokyo Metropolitan Ohtsuka Hospital
Division name
Department of Anesthesiology
Zip code
Address
2-8-1, Minamiohtsuka, Toshima-ku, Tokyo
TEL
03+3941+3211
Homepage URL
mistysky_aaa@yahoo.co.jp
Sponsor or person
Institute
Tokyo Metropolitan Ohtsuka 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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 02 | Month | 12 | 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
Preinitiation
Date of protocol fixation
| 2015 | Year | 02 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 04 | Month | 01 | 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 | 02 | Month | 12 | Day |
Last modified on
| 2016 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019184
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