UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015576 |
|---|---|
| Receipt number | R000017887 |
| Scientific Title | Evaluation of ultrasound-guided confirmation technique of paravertebral catheter tip location |
| Date of disclosure of the study information | 2014/10/31 |
| Last modified on | 2018/03/31 10:21:57 |
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Basic information
Public title
Evaluation of ultrasound-guided confirmation technique of paravertebral catheter tip location
Acronym
Ultrasound-guided confirmation technique of paravertebral catheter tip location
Scientific Title
Evaluation of ultrasound-guided confirmation technique of paravertebral catheter tip location
Scientific Title:Acronym
Ultrasound-guided confirmation technique of paravertebral catheter tip location
Region
| Japan |
Condition
Condition
Unilateral video-assisted thoracic surgery
Classification by specialty
| Chest surgery | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine accuracy of ultrasound-guided confirmation technique of paravertebral catheter tip location.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Success rate of a continuous thoracic paravertebral block
Key secondary outcomes
Spread of sensory block
Pain score
Incidence of PONV
Sedation scale
Incidence of local anesthetic systemic toxicity
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
1. Patients undergoing a unilateral video-assisted surgery
2. American Society of Anesthesiologists PS: 1-3
3. Written informed consent is provided
Key exclusion criteria
1. Inability to communicate lucidly
2. Under 20 or over 80 years old
3. Postero-lateral thoracotomy reaching within 2 cm from the catheter insertion site
4. Inability to observe the paravertebral space under ultrasound
5. Body weight <40 kg
6. Contraindication or allergy to drugs used in this study
7. Pre-existing sensory disturbance of the trunk
8. Patients who are regarded ineligible by researchers with any other reasons
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenta Furutani |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Division of Anesthesiology
Zip code
Address
1-757, Asahimachi-dori Chuo-ku Niigata, JAPAN
TEL
025-227-2328
kenta-f@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takayuki Yoshida |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Division of Anesthesiology
Zip code
Address
1-757, Asahimachi-dori Chuo-ku Niigata, JAPAN
TEL
025-227-2328
Homepage URL
ytaka@mac.com
Sponsor or person
Institute
Niigata University Medical and Dental Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
新潟大学医歯学総合病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 10 | Month | 31 | 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 | 11 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 11 | Month | 07 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 03 | Month | 31 | Day |
Other
Other related information
Correlation of paravertebral block success rate and presence of catheter tip location confirmation under ultrasound guidance
Management information
Registered date
| 2014 | Year | 10 | Month | 31 | Day |
Last modified on
| 2018 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017887
