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Recruitment status Completed
Unique ID issued by UMIN UMIN000017875
Receipt No. R000020706
Official scientific title of the study Efficacy of Pectoral nerve block for perioperative pain management in breast cancer surgery
Date of disclosure of the study information 2015/06/11
Last modified on 2015/06/11

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Basic information
Official scientific title of the study Efficacy of Pectoral nerve block for perioperative pain management in breast cancer surgery
Title of the study (Brief title) Retrospective evaluation of PECS block in breast cancer surgery
Region
Japan

Condition
Condition breast cancer
Classification by specialty
Breast surgery Anesthesiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of PECS block for perioperative pain management in breast cancer surgery
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Quantitiy of opioids usage during breast cancer surgery and postoperative pain during 48 hour after surgery
Key secondary outcomes Usage of supplemental analgesics during 48 hour after surgery and incidence of PONV and other adverse events

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 general anesthesia without PECS block
Interventions/Control_2 general anesthesia with PECS block
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
80 years-old >=
Gender Female
Key inclusion criteria The patients who underwent breast cancer surgery at Niigata University Medical and Dental Hospital, and did not express obvious refusa lfor the research use of the one's medical records
Key exclusion criteria The patients who did not agree for research use of one's medical records
The patients whose medical records were incomplete
The patients who has abnormal sensation in the body trunk
The patients who already used opioids for pain control
Target sample size 80

Research contact person
Name of lead principal investigator Yoshinori Kamiya
Organization Niigata University Medical and Dental Hospital
Division name Division of Anesthesiology
Address 1-754 Asahimachi-dori, Chuo ward, Niigata 950-8570, Japan
TEL 025-227-2328
Email y-kamiya@med.niigata-u.ac.jp

Public contact
Name of contact person Yoshinori Kamiya
Organization Niigata University Medical and Dental Hospital
Division name Division of Anesthesiology
Address 1-754 Asahimachi-dori, Chuo ward, Niigata 950-8570, Japan
TEL 025-227-2328
Homepage URL
Email y-kamiya@med.niigata-u.ac.jp

Sponsor
Institute Niigata University Medical and Dental Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization none
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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 06 Month 11 Day

Progress
Recruitment status Completed
Date of protocol fixation
2014 Year 03 Month 11 Day
Anticipated trial start date
2015 Year 06 Month 11 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Partially published
URL releasing results
Results
Other related information

Management information
Registered date
2015 Year 06 Month 11 Day
Last modified on
2015 Year 06 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020706


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