UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043549 |
|---|---|
| Receipt number | R000049694 |
| Scientific Title | Effect of combined PECS1 block with serratus plane block for postoperative pain after total mastectomy |
| Date of disclosure of the study information | 2021/03/15 |
| Last modified on | 2023/03/11 10:28:43 |
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Basic information
Public title
Effect of combined pectoral nerve block(PECS)1 block with serratus plane block for postoperative pain after total mastectomy
Acronym
Effect of combined pectoral nerve block(PECS)1 block with serratus plane block for postoperative pain after total mastectomy
Scientific Title
Effect of combined PECS1 block with serratus plane block for postoperative pain after total mastectomy
Scientific Title:Acronym
Effect of combined PECS1 block with serratus plane block for postoperative pain after total mastectomy
Region
| Japan |
Condition
Condition
post-mastectomy pain syndrome
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the efficacy of combined PECS1 and seratus plane blocks for postoperative breast pain.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
NRS at rest 6 months after surgery
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
0.375% Ropivacaine(10ml) will be administered for PECS1 block prior to mastectomy after induction of general anesthesia.
Interventions/Control_2
Normal saline(10ml) will be administered for PECS1 block prior to mastectomy after induction of 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
Adult women with ASA-PS 1 or 2 undergoing unilateral total mastectomy.
This includes cases in which sentinel lymph node resection or axillary lymph node dissection is performed.
Key exclusion criteria
Simultaneous bilateral surgery, insertion of breast expanders and implants, endoscopic surgery, history of breast surgery, allergy to target drugs, asthma, psychiatric disorders, hepatic, renal, and coagulation dysfunction
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | kono |
| Middle name | |
| Last name | hiroyuki |
Organization
kameda medical center
Division name
Department of Anesthesiology
Zip code
296-8602
Address
929 Higashi-machi, Kamogawa-shi, Chiba
TEL
04-7092-2211
kono.hiroyuki@kameda.jp
Public contact
Name of contact person
| 1st name | kono |
| Middle name | |
| Last name | hiroyuki |
Organization
kameda medical center
Division name
Department of Anesthesiology
Zip code
296-8602
Address
929 Higashi-machi, Kamogawa-shi, Chiba
TEL
04-7092-2211
Homepage URL
kono.hiroyuki@kameda.jp
Sponsor or person
Institute
kameda medical center
Institute
Department
Personal name
Funding Source
Organization
self funding
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
kameda medical center
Address
929 Higashi-machi, Kamogawa-shi, Chiba
Tel
04-7092-2211
clinical_research@kameda.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
| 2021 | Year | 03 | Month | 15 | 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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 02 | Month | 24 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 24 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 11 | Day |
Last follow-up date
| 2023 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 08 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 03 | Month | 08 | Day |
Last modified on
| 2023 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049694
