UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A comparison of effectiveness of epidural analgesia with continuous rectus sheath block for upper abdominal surgery -mobilization and postoperative pain
Title of the study (Brief title)	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	Kochi Yamane
Organization	Yokkaichi Municipal hospital
Division name	Department of anesthesiology and critical care medicine
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	Kochi Yamane
Organization	Yokkaichi Municipal hospital
Division name	Department of anesthesiology and critical care medicine
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 10 Month 20 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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