UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033790
Receipt No. R000038548
Scientific Title The comparison of the clinical effect between retrolaminar block and erector spinae plane block
Date of disclosure of the study information 2018/08/17
Last modified on 2019/09/29

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title The comparison of the clinical effect between retrolaminar block and erector spinae plane block
Acronym The comparison of the clinical effect between retrolaminar block and erector spinae plane block
Scientific Title The comparison of the clinical effect between retrolaminar block and erector spinae plane block
Scientific Title:Acronym The comparison of the clinical effect between retrolaminar block and erector spinae plane block
Region
Japan

Condition
Condition surgical patient
Classification by specialty
Anesthesiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The comparison of the clinical effect between the retrolaminar block and the erector spinae plane block for the postoperative analgesia in the patients of mastectomy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The duration of the first additional analgesics after the retrolaminar block or the erector spinae plane block
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Single blind -participants are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 The administration of the retrolaminar block or the erector spinae plane blosk for the postoperative analgesia in the patients with mastectomy
Interventions/Control_2 the day of surgery
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
100 years-old >
Gender Female
Key inclusion criteria ASA physical status I or II
Key exclusion criteria The allergy of local analgesics, the usage of opioids in the preoperative period
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Atsushi
Middle name
Last name Sawada
Organization Sapporo Medical University, School of Medicine
Division name Depart
Zip code 060-8543
Address South 1 West 16, Chu-o-ku, Sapporo
TEL 0116112111
Email atusihon7@gmail.com

Public contact
Name of contact person
1st name Atsushi
Middle name
Last name Sawada
Organization Sapporo Medical University School of Medicine
Division name Department of Anesthesiology
Zip code 060-8543
Address South 1 West 16, Chu-o-ku, Sapporo
TEL 0116112111
Homepage URL
Email atusihon7@gmail.com

Sponsor
Institute Sapporo Medical University School of Medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization JP

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

IRB Contact (For public release)
Organization Sapporo Medical University School of Medicine
Address South 1, West 16, Chuo-ku, Sapporo
Tel 0116112111
Email atusihon7@gmail.com

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
2018 Year 08 Month 17 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
2018 Year 08 Month 15 Day
Date of IRB
2018 Year 08 Month 14 Day
Anticipated trial start date
2018 Year 08 Month 17 Day
Last follow-up date
2021 Year 03 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
2018 Year 08 Month 17 Day
Last modified on
2019 Year 09 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038548

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.