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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032735
Receipt No. R000037318
Scientific Title Comparison of the effects of analgesia for patients undergoing laparoscopic hepatectomy:epidural versus continuous infusion of fentanyl.
Date of disclosure of the study information 2018/05/28
Last modified on 2019/06/06

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Basic information
Public title Comparison of the effects of analgesia for patients undergoing laparoscopic hepatectomy:epidural versus continuous infusion of fentanyl.
Acronym Comparison of the effects of analgesia for patients undergoing laparoscopic hepatectomy:epidural versus continuous infusion of fentanyl.
Scientific Title Comparison of the effects of analgesia for patients undergoing laparoscopic hepatectomy:epidural versus continuous infusion of fentanyl.
Scientific Title:Acronym Comparison of the effects of analgesia for patients undergoing laparoscopic hepatectomy:epidural versus continuous infusion of fentanyl.
Region
Japan

Condition
Condition Patients scheduled for elective laparoscopic hepatectomy
Classification by specialty
Hepato-biliary-pancreatic surgery Anesthesiology Operative medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to compare the effects of analgesia for patients scheduled for elective laparoscopic hepatectomy:epidural versus continuous infusion of fentanyl.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes MPADSS(modified post-anaesthesia discharge scoring system)scores for the first 42 postoperative hours.
Key secondary outcomes Pain scores at rest and while coughing for the first 42 postoperative hours.
Additional analgesics.
The number of PCA bolus.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Epidural analgesia after laparoscopic hepatectomy
Interventions/Control_2 Continuous intravenous fentanyl analgesia after laparoscopic hepatectomy
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
80 years-old >
Gender Male and Female
Key inclusion criteria Man and women over 20year old
Patients scheduled for laparoscopic hepatectomy
Key exclusion criteria Open hepatectomy
Decision as ineligible by principal anaesthesiologist.
Patients with parkinson disease.
Contraindication for any of the drugs used in this study.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Azusa
Middle name
Last name Mori
Organization Ikeda City Hospital
Division name Department of Anesthesiology
Zip code 5638510
Address 3-1-18,Jyonan,Ikeda City ,Osaka,Japan
TEL 0727512881
Email azuazumorimori@yahoo.co.jp

Public contact
Name of contact person
1st name Azusa
Middle name
Last name Mori
Organization Ikeda City Hospital
Division name Department of Anesthesiology
Zip code 5638510
Address 3-1-18,Jyonan,Ikeda City ,Osaka,Japan
TEL 0727512881
Homepage URL
Email azuazumorimori@yahoo.co.jp

Sponsor
Institute Ikeda City Hospital
Institute
Department

Funding Source
Organization Ikeda City Hospital
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor none
Name of secondary funder(s) none

IRB Contact (For public release)
Organization Ikeda City Hospital
Address 3-1-18,Jyonan,Ikeda City ,Osaka,Japan
Tel 0727512881
Email keiko-irishio@hosp.ikeda.osaka.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
2018 Year 05 Month 28 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 Open public recruiting
Date of protocol fixation
2018 Year 05 Month 29 Day
Date of IRB
Anticipated trial start date
2018 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 05 Month 27 Day
Last modified on
2019 Year 06 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037318

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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