UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019186 |
|---|---|
| Receipt number | R000022177 |
| Scientific Title | A comparative investigation about analgesic effect after esophageal surgery between opioid and acetaminophen. |
| Date of disclosure of the study information | 2015/10/02 |
| Last modified on | 2018/10/11 21:33:23 |
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Basic information
Public title
A comparative investigation about analgesic effect after esophageal surgery between opioid and acetaminophen.
Acronym
A comparative investigation about analgesic effect after esophageal surgery between opioid and acetaminophen.
Scientific Title
A comparative investigation about analgesic effect after esophageal surgery between opioid and acetaminophen.
Scientific Title:Acronym
A comparative investigation about analgesic effect after esophageal surgery between opioid and acetaminophen.
Region
| Japan |
Condition
Condition
Esophageal Cancer
Classification by specialty
| Gastrointestinal surgery | Operative medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To prove the equivalent analgestic effect between acetaminophen and opioid, after esophageal surgery.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
pain (until 7days after surgery.)
Key secondary outcomes
The time of first walking after surgery.
The kind and the number of rescue dose.
Consciousness.
The extent of nausea.
The bowel movement.
All side effects.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Using asetaminophen until 7 days after surgery.
4 times per a day, 15mg/kg.
Interventions/Control_2
Using opioid until 7 days after surgery.
Continuous injection, 0.6 microgram of phentanyl per kilogram(body weight) per hour.
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
1. a person older than 20 years old.
2. sex dose not matter.
3. a person who was informed sufficiently, and agree to perticipate this study of one's free will.
Key exclusion criteria
A person who had contraindication about the treatment bellow,
1. epidural analgesia.
2. using acetaminophen.
3. using NSAIDs.
4. using fentanyl.
A person who was unsuitable for this study.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuaki Nakajima |
Organization
Depatment of digestive surgery, Tokyo Medical and Dental University
Division name
Esophageal and general surgery
Zip code
Address
1-5-45, Yushima, Bunkyo-city, Tokyo, Japan
TEL
03-5803-5254
yasu.nakajima.srg1@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuichiro Kume |
Organization
Department of digestive surgery, Tokyo Medical and Dental University
Division name
Esophageal and general surgery
Zip code
Address
1-5-45, Yushima, Bunkyo-city, Tokyo, Japan
TEL
03-5803-5254
Homepage URL
yuukun@yg8.so-net.ne.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
nothing
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
東京医科歯科大学附属病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 10 | Month | 02 | 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
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
| 2015 | Year | 10 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 02 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 17 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 10 | Month | 01 | Day |
Last modified on
| 2018 | Year | 10 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022177
