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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000029639
Receipt No. R000033745
Scientific Title A comparison of effectiveness of epidural analgesia with continuous rectus sheath block for upper abdominal surgery -mobilization and postoperative pain
Date of disclosure of the study information 2017/10/20
Last modified on 2017/10/19

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Basic information
Public title A comparison of effectiveness of epidural analgesia with continuous rectus sheath block for upper abdominal surgery -mobilization and postoperative pain
Acronym A comparison of effectiveness of epidural analgesia with continuous rectus sheath block for upper abdominal surgery
Scientific Title A comparison of effectiveness of epidural analgesia with continuous rectus sheath block for upper abdominal surgery -mobilization and postoperative pain
Scientific Title:Acronym A comparison of effectiveness of epidural analgesia with continuous rectus sheath block for upper abdominal surgery
Region
Japan

Condition
Condition upper abdominal open surgery
Classification by specialty
Gastrointestinal surgery Hepato-biliary-pancreatic surgery Anesthesiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of the study is to compare epidural analgesia with continuous rectus sheath block for effectiveness of pain management and mobilization in upper abdominal open surgery.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes achievement ratio of mobilization on postoperative second day
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
85 years-old >
Gender Male and Female
Key inclusion criteria Planned upper abdominal surgery(right side colonic surgery gastrointestinal surgery pancreatic surgery)
Preoperative ADL is independent
Willing and able to give consent
ASA(American society anesthesiologistphysical status )1 to 3
Key exclusion criteria Consent refused for epidural analgesia and rectus sheath block
Allergy to local anesthetic drugs or opiates
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kochi Yamane
Organization Yokkaichi Municipal hospital
Division name Department of anesthesiology and critical care medicine
Zip code
Address 2-37 shibata 2-chome Yokkaichi-shi Mie 510-8567
TEL 059-354-1111
Email yamanekoken_com4@yokkaichihp01.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kochi Yamane
Organization Yokkaichi Municipal hospital
Division name Department of anesthesiology and critical care medicine
Zip code
Address 2-37 shibata 2-chome Yokkaichi-shi Mie 510-8567
TEL 059-354-1111
Homepage URL
Email yamanekoken_com4@yokkaichihp01.jp

Sponsor
Institute Yokkaichi Municipal hospital
Institute
Department

Funding Source
Organization Yokkaichi Municipal hospital
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2017 Year 10 Month 20 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
2017 Year 10 Month 20 Day
Date of IRB
Anticipated trial start date
2017 Year 10 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Comparing achievement ratio of mobilization on postoperative second day
Definition of mobilization : patient can walk 10 m without assistance

Management information
Registered date
2017 Year 10 Month 20 Day
Last modified on
2017 Year 10 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033745

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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