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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043549
Receipt No. 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 2021/03/08

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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
Email 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
Email kono.hiroyuki@kameda.jp

Sponsor
Institute kameda medical center
Institute
Department

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
Email 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 Preinitiation
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 03 Month 15 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
2023 Year 03 Month 31 Day
Date trial data considered complete
2023 Year 03 Month 31 Day
Date analysis concluded
2023 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2021 Year 03 Month 08 Day
Last modified on
2021 Year 03 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049694

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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