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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000025894
Receipt No. R000029771
Scientific Title Feasibility and safety of fentanyl with acetaminophen for pain control after liver resection
Date of disclosure of the study information 2017/01/30
Last modified on 2019/08/02

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Basic information
Public title Feasibility and safety of fentanyl with acetaminophen for pain control after liver resection
Acronym Feasibility and safety of fentanyl with acetaminophen for pain control after liver resection
Scientific Title Feasibility and safety of fentanyl with acetaminophen for pain control after liver resection
Scientific Title:Acronym Feasibility and safety of fentanyl with acetaminophen for pain control after liver resection
Region
Japan

Condition
Condition liver disease (HCC, liver meta, ICC, living donor stc)
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to clarify the influence of acetoaminophen to liver function after liver resection and to assess the feasibility of pain controlusing fentanyl with acetoaminophen after liver resection
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes Blood oncentration of Acetoaminophen
Liver dysfunction after liver resection
Complications
Key secondary outcomes Assessment of pain
Dose of drug

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 prospective cohort
Fentanyl with acetoaminophen
1.Fentanyl(continuous):0.5microg/kg/hr(POD0-3)
2.Acetoaminophen (every 6hours) :15mg/kg/every 6 hours(POD0-3)
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

Not applicable
Gender Male and Female
Key inclusion criteria 1.patient with liver function as Child-Pugh Grade A
2.Age over 20 years old
3.gender: free
4.Admission
5.Patients obtained informed concent
Key exclusion criteria 1. Inappropriate patient for this research
2. patient with local inflammation in the injection site
3. sepsis
4. central nerve disorder
5. spinal cord disorder
6. contraindication for muscle relaxant agent
7. patient with respiratory disorder
8. convulsive seizure
9. asthma
10. sever liver dysfunction
11. gastric or duodenal ulcer
12. severe blood disease
13. severe renal dysfunction
14. sever heart failure
15. aspirin asthma
16. hypersensitivity for fentanyl or acetoaminophen
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Masaaki
Middle name
Last name HIDAKA
Organization Nagasaki University Hospital
Division name Department of Surgery
Zip code 852-8501
Address 1-7-1sakamoto, Nagasaki
TEL 095-819-7316
Email mahidaka@nagasaki-u.ac.jp

Public contact
Name of contact person
1st name Masaaki
Middle name
Last name HIDAKA
Organization Nagasaki University Hospital
Division name Department of Surgery
Zip code 852-8501
Address 1-7-1sakamoto, Nagasaki
TEL 095-819-7316
Homepage URL
Email mahidaka@nagasaki-u.ac.jp

Sponsor
Institute Nagasaki University Hospital
Institute
Department

Funding Source
Organization self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Nagasaki University Hospital
Address 1-7-1 Sakamoto, Nagasaki city
Tel 0958197316
Email mahidaka@nagasaki-u.ac.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 長崎大学病院

Other administrative information
Date of disclosure of the study information
2017 Year 01 Month 30 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled 50
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 No longer recruiting
Date of protocol fixation
2017 Year 01 Month 29 Day
Date of IRB
2017 Year 01 Month 24 Day
Anticipated trial start date
2017 Year 02 Month 10 Day
Last follow-up date
2019 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 01 Month 29 Day
Last modified on
2019 Year 08 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029771

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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