UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017541 |
|---|---|
| Receipt number | R000020084 |
| Scientific Title | Effects of opioids on paravertebral nerve block. |
| Date of disclosure of the study information | 2015/05/13 |
| Last modified on | 2016/03/16 14:53:11 |
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Basic information
Public title
Effects of opioids on paravertebral nerve block.
Acronym
Effects of opioids on paravertebral nerve block.
Scientific Title
Effects of opioids on paravertebral nerve block.
Scientific Title:Acronym
Effects of opioids on paravertebral nerve block.
Region
| Japan |
Condition
Condition
Patients undergoing surgery with paravertebral nerve block
Classification by specialty
| Anesthesiology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We reserch the efficasy of opioids added to local anesthetic on paravertebral block.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intensity of pain
Key secondary outcomes
The amount used of analgesic drug
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
without morphine
Interventions/Control_2
morphine 50 mcg/kg/day
Interventions/Control_3
morphine 100 mcg/kg/day
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
Key inclusion criteria
patients undergoing paravertebral block
Key exclusion criteria
ideal body weight <70% or >130%
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masanori Kawaguchi |
Organization
National Dffense Medical Collage
Division name
Department of Anesthesiology
Zip code
Address
3-2 Namiki, Tokorozawa, Japan
TEL
04-2995-1511
kawaguchi711@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masanori Kawaguchi |
Organization
National Dffense Medical Collage
Division name
Department of Anesthesiology
Zip code
Address
3-2 Namiki, Tokorozawa, Japan
TEL
04-2995-1511
Homepage URL
kawgaguchi711@yahoo.co.jp
Sponsor or person
Institute
National Dffense Medical Collage
Institute
Department
Personal name
Funding Source
Organization
National Dffense Medical Collage
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
| 2015 | Year | 05 | Month | 13 | 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
| 2015 | Year | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 04 | Month | 28 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2016 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 05 | Month | 13 | Day |
Last modified on
| 2016 | Year | 03 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020084
