UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015988 |
|---|---|
| Receipt number | R000018490 |
| Scientific Title | n analysis of paravertebral catheters placement and spread compared ultrasound-guided paravertebral block transverse plane approach and sagittal plane approach. |
| Date of disclosure of the study information | 2015/02/01 |
| Last modified on | 2016/06/18 10:55:22 |
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Basic information
Public title
n analysis of paravertebral catheters placement and spread compared ultrasound-guided paravertebral block transverse plane approach and sagittal plane approach.
Acronym
n analysis of paravertebral catheters placement and spread compared ultrasound-guided paravertebral block transverse plane approach and sagittal plane approach.
Scientific Title
n analysis of paravertebral catheters placement and spread compared ultrasound-guided paravertebral block transverse plane approach and sagittal plane approach.
Scientific Title:Acronym
n analysis of paravertebral catheters placement and spread compared ultrasound-guided paravertebral block transverse plane approach and sagittal plane approach.
Region
| Japan |
Condition
Condition
Thoracic surgery (Unilateral thoracotomy and video-assisted thoracoscopic surgery)
Classification by specialty
| Chest surgery | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Ultrasound-guided paravertebral block, there are two techniques of transverse plane approach and sagittal plane approach. Consider tip position and spread of solution of the paravertebral catheters by approach of these ultrasound-guided paravertebral block approaches, to evaluate and its effectiveness approach more effective paravertebral block.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Paravertebral catheters placement
Key secondary outcomes
Spread of drug solution
VAS after surgery 24 hours
Number of times of use iv-PCA
Frequency of use iv-PCA
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
| Maneuver |
Interventions/Control_1
Transverse plane approach of ultrasound guided paravertebral block
Interventions/Control_2
Saggital plane approach of ultrasound guided paravertebral block
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patient of lung cancer
Scheduled thoracotomy or thoracoscopic surgery.
ASA classification(class1, class2)
Document those obtained consent
Key exclusion criteria
Emergency surgery.
ASA classification class3 or more.
Patients and including a history, convulsions, there is epilepsy and its quality.
Patients with a history and existing bronchial asthma.
Patients with a history of some of-iodine or contrast agent allergy.
Patients, a thyroid disease.
Clotting disorder Some of the (less than 100,000 platelets/10-3ml, PT-INR is 2 or more or APTT% is less than 70%).
Renal dysfunction (less than eGFR60).
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kimitoshi Nishiwaki |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Anesthesiology
Zip code
Address
65 Tsuruna-cho, Showa-ku, Nagoya, 466-8550 Japan
TEL
052-744-2340
nishi@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tasuku Fujii |
Organization
Nagoya University Hospital
Division name
Department of Anesthesiology
Zip code
Address
65 Tsuruna-cho, Showa-ku, Nagoya, 466-8550 Japan
TEL
052-744-2340
Homepage URL
plus9@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine, Biomedical Regulation, Department of Anesthesiology
Institute
Department
Personal name
Funding Source
Organization
Nagoya University Graduate School of Medicine
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
名古屋大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 02 | 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
| 2014 | Year | 12 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 12 | Month | 18 | Day |
Last modified on
| 2016 | Year | 06 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018490
