UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025894 |
|---|---|
| Receipt number | 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 | 2021/09/13 08:56:38 |
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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
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
mahidaka@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University Hospital
Institute
Department
Personal name
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
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
https://pubmed.ncbi.nlm.nih.gov/33421327/
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/10.1002/jhbp.892
Number of participants that the trial has enrolled
50
Results
Results: The alanine transaminase level on postoperative days 1, 5, and 7 and total bilirubin on postoperative days 1 to 5 after LR in patients with more than one section LR was significantly higher than the levels in patients with partial resection. No patients developed liver failure. The blood concentration of acetaminophen by HPLC was significantly elevated in patients with resection of more than one section in comparison to the partial resection group.
Results date posted
| 2021 | Year | 09 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 02 | Month | 02 | Day |
Baseline Characteristics
Patients with liver resection
Participant flow
Acetaminophen was used in postoperative pain management for hepatectomy patients, and liver function and acetaminophen blood levels were measured.
We thereby assessed the safety of acetaminophen use after hepatectomy.
Adverse events
nothing
Outcome measures
We analyzed the liver function and blood concentration of acetaminophen at 1 and 3 days after LR using high performance liquid chromatography (HPLC), and investigated the results of partial and more than one section LR, and also examined the degree of liver fibrosis.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 01 | Month | 22 | Day |
Date of IRB
| 2017 | Year | 01 | Month | 24 | Day |
Anticipated trial start date
| 2017 | Year | 02 | Month | 10 | Day |
Last follow-up date
| 2018 | Year | 08 | Month | 15 | Day |
Date of closure to data entry
| 2018 | Year | 09 | Month | 10 | Day |
Date trial data considered complete
| 2018 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2019 | Year | 01 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 01 | Month | 29 | Day |
Last modified on
| 2021 | Year | 09 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029771
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