UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026257 |
|---|---|
| Receipt number | R000030100 |
| Scientific Title | The effect of intravenous acetaminophen on postoperative pain control after esophageal cancer surgery, a prospective randomized study. |
| Date of disclosure of the study information | 2017/04/01 |
| Last modified on | 2019/03/01 16:25:31 |
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Basic information
Public title
The effect of intravenous acetaminophen on postoperative pain control after esophageal cancer surgery, a prospective randomized study.
Acronym
The effect of intravenous acetaminophen on postoperative pain control after esophageal cancer surgery, a prospective randomized study.
Scientific Title
The effect of intravenous acetaminophen on postoperative pain control after esophageal cancer surgery, a prospective randomized study.
Scientific Title:Acronym
The effect of intravenous acetaminophen on postoperative pain control after esophageal cancer surgery, a prospective randomized study.
Region
| Japan |
Condition
Condition
Esophageal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To prove the efficacy of intravenous acetamonophen on postoperative pain control after esophageal cancer surgery compared with epidural anesthesia alone.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase III
Assessment
Primary outcomes
The frequency of analgesic rescue dose
Key secondary outcomes
Side effect of opioid
Pain(until 7 days after surgery)
The days until first gait, flatus, and constipation after surgery
Hospital stay days after surgery
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Using asetaminophen until 7days after surgery.
4 times per a day, 15mg/kg
Combination with epidural anesthesia
Interventions/Control_2
Not using asetaminophen.
Only epidural anesthesia
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
a person older than 20 years old
sex dose not matter
a person who was informed sufficiently, and agree to participate this study of one's free will
Key exclusion criteria
A person who had contraindication about treatment below,
1,Epidural analgesia
2,using acetaminophen
3,using NSAIDs
A person who do not agree to participate this study and was unsuitable for this study
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akira Tangoku |
Organization
Tokushima university and graduated school,
Division name
Thoracic, endocrine oncology and surgery
Zip code
Address
18-15, Kuramotocho,Tokushima,Japan
TEL
088-633-7173
tangoku@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takeshi Nishino |
Organization
Tokushima university and graduated school
Division name
Thoracic, endocrine oncology and surgery
Zip code
Address
18-15, Kuramotocho,Tokushima,Japan
TEL
088-633-7173
Homepage URL
nishinotakeshi@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima university
Institute
Department
Personal name
Funding Source
Organization
None
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
Address
Tel
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 | 04 | Month | 01 | 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
Completed
Date of protocol fixation
| 2017 | Year | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 17 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 02 | Month | 21 | Day |
Last modified on
| 2019 | Year | 03 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030100
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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