UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026381 |
|---|---|
| Receipt number | R000029913 |
| Scientific Title | Effectiveness of postoperative pain control with intravenous acetaminophen (Acelio) following esophageal cancer surgery: A prospective randomize controlled trial |
| Date of disclosure of the study information | 2017/04/01 |
| Last modified on | 2017/09/02 09:07:36 |
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Basic information
Public title
Effectiveness of postoperative pain control with intravenous acetaminophen (Acelio) following esophageal cancer surgery: A prospective randomize controlled trial
Acronym
Effectiveness of postoperative pain control with intravenous acetaminophen (Acelio) following esophageal cancer surgery: A prospective randomize controlled trial
Scientific Title
Effectiveness of postoperative pain control with intravenous acetaminophen (Acelio) following esophageal cancer surgery: A prospective randomize controlled trial
Scientific Title:Acronym
Effectiveness of postoperative pain control with intravenous acetaminophen (Acelio) following esophageal cancer surgery: A prospective randomize controlled trial
Region
| Japan |
Condition
Condition
Esophageal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To prove positive effect of intravenous acetaminophen in pain control after esophageal cancer surgery added to epidural anesthesia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Reduce of additional dosage of epidual anesthesia by patient control pump and dosage of NSAIDs as rescue drug.
Key secondary outcomes
Reduce complaint related to opioid,reduce pain, the time of first gait, flatus, constipation,and hospital stay
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
The group with intravenous acetaminofen administration around the clock
Interventions/Control_2
The group without intravenous acetaminofen administration
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The patients planed to recieve thoracoscope assisted esophagectomy and hand assisted laparoscopic gastric tube reconstruction and 2 or 3 fields lymphoadenectomy.
Maintain major organ function
Got an informed consent
Key exclusion criteria
Open thoracotomy or open laparotpmy case
One or more wound size over 10 cm in cervial ,thoracic, or abdominal incision.
With major organ disfunction.
Target sample size
60
Research contact person
Name of lead principal investigator
| 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
nishinotakeshi@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 and graduated school
Institute
Department
Personal name
Funding Source
Organization
Tokushima university and graduated school
Organization
Division
Category of Funding Organization
Other
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
Four patients
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
| 2017 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 03 | Month | 03 | Day |
Last modified on
| 2017 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029913
| 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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