UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013471 |
|---|---|
| Receipt number | R000015727 |
| Scientific Title | comparison of continuous rectus sheath block and continuous intravenous opioid use after abdominal surgery |
| Date of disclosure of the study information | 2014/03/20 |
| Last modified on | 2015/09/22 08:54:03 |
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Basic information
Public title
comparison of continuous rectus sheath block and continuous intravenous opioid use after abdominal surgery
Acronym
comparison of continuous rectus sheath block and continuous intravenous opioid use after abdominal surgery
Scientific Title
comparison of continuous rectus sheath block and continuous intravenous opioid use after abdominal surgery
Scientific Title:Acronym
comparison of continuous rectus sheath block and continuous intravenous opioid use after abdominal surgery
Region
| Japan |
Condition
Condition
malignant tumor
Classification by specialty
| Surgery in general | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
comparison of pain,blood concentration of local analgesia,heart rate variability analysis and side effect after abdominal malignat tumor surgery between continuous rectus sheath block and continuous intravenous opioid use
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
pain
Key secondary outcomes
blood concentration of local analgesia
heart rate variability analysis
complication
Base
Study type
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
rectus sheath block
Interventions/Control_2
intravenous opioid use
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
patient who takes open abdominal mailignagt surgery
Key exclusion criteria
the patient who do not consent with this study
the patient who has dementia to take pain scale
the patient who has allergic to local analgesia
the patient who has allergic to opioid
the patient who judged other chief physicians to be inappropriate about the study concerned
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | kazuo ando |
Organization
aichi medical university hospital
Division name
anesthesiology
Zip code
Address
karimata1-1 yazako nagakute aichi
TEL
0561623311
ando_kazuo0210@hotmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | kazuo ando |
Organization
aichi medical university hospital
Division name
anesthesiology
Zip code
Address
karimata1-1 yazako nagakute aichi
TEL
0561623311
Homepage URL
ando_kazuo0210@hotmail.com
Sponsor or person
Institute
aichi medical university hospital
Institute
Department
Personal name
Funding Source
Organization
aichi medical university hospital
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
| 2014 | Year | 03 | Month | 20 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 03 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 03 | Month | 20 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 03 | Month | 20 | Day |
Last modified on
| 2015 | Year | 09 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015727
