UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016472 |
|---|---|
| Receipt number | R000019135 |
| Scientific Title | An analysis of catheterization and solution spread in ultrasound-guided paravertebral block under thoracoscopy |
| Date of disclosure of the study information | 2015/02/25 |
| Last modified on | 2018/12/11 09:31:39 |
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Basic information
Public title
An analysis of catheterization and solution spread in ultrasound-guided paravertebral block under thoracoscopy
Acronym
An analysis of catheterization and solution spread in ultrasound-guided paravertebral block under thoracoscopy
Scientific Title
An analysis of catheterization and solution spread in ultrasound-guided paravertebral block under thoracoscopy
Scientific Title:Acronym
An analysis of catheterization and solution spread in ultrasound-guided paravertebral block under thoracoscopy
Region
| Japan |
Condition
Condition
video-assisted thoracic surgery
Classification by specialty
| Chest surgery | Anesthesiology | Operative medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In direct observation by thoracoscopy, by performing an ultrasound-guided paravertebral block can be considered the paravertebral catheter placement and the spread of solution. Thereby, this research evaluates the approach of safer and more effective by ultrasound-gaidied paravertebral block.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Spread type of the solution
Key secondary outcomes
Distance of the paravertebral catheter placement
Success rate of catheterization
(same intercostal level)
Check of paravertebral catheter by saline mixed air under ultrasound
Postoperative pain(VAS)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are 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
ultrasound-guided paravertebral block
(10ml injection group:saline)
(Later, local anesthetic 20ml injection from the catheter)
Interventions/Control_2
ultrasound-guided paravertebral block(30ml injection group:10mlsaline+20ml local anesthetic)
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
Elective video-assisted thoracic surgery patients (lung cancer, mediastinal tumor, pneumothorax, interstitial pneumonia, etc.)
20 years of age or older
ASA physical status classification(class1, class2)
Key exclusion criteria
Minor
Impaired consciousness
There is not enough judgment ability
Emergency surgery
Class3 more ASA classification
hypersensitivity to ropivacaine or amide type local anesthetic
Hemodialysis
Advanced renal dysfunction(less than eGFR30)
Liver dysfunction (Child-Pugh classification more B)
Target sample size
34
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
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Tosei General Hospital
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
公立陶生病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 02 | Month | 25 | 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
| 2015 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | 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 | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 02 | Month | 08 | Day |
Last modified on
| 2018 | Year | 12 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019135
