UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032267 |
|---|---|
| Receipt number | R000036796 |
| Scientific Title | Distribution of injectate administered through a catheter inserted by ultrasound-guided thoracic paravertebral block: A prospective observational study |
| Date of disclosure of the study information | 2018/04/17 |
| Last modified on | 2020/03/13 16:01:43 |
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Basic information
Public title
Distribution of injectate administered through a catheter inserted by ultrasound-guided thoracic paravertebral block: A prospective observational study
Acronym
Distribution of injectate administered through a catheter inserted by ultrasound-guided thoracic paravertebral block: A prospective observational study
Scientific Title
Distribution of injectate administered through a catheter inserted by ultrasound-guided thoracic paravertebral block: A prospective observational study
Scientific Title:Acronym
Distribution of injectate administered through a catheter inserted by ultrasound-guided thoracic paravertebral block: A prospective observational study
Region
| Japan |
Condition
Condition
lung cancer
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To observe distribution of injectate administered through a catheter inserted by performing ultrasound-guided thoracic paravertebral block (TPVB).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
spread pattern of dye in paravertebral space following ultrasound guided paravertebral block
Key secondary outcomes
distribution of cutaneous sensory blocakde
Visual Analogue Scale
postoperative use of analgesics
complications regarding block
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
American Society of Anesthesiologists physical status 1-3
Key exclusion criteria
contraindications to paravertebral block
Body mass index >35
Allergy to study medications
preoperative opioid use
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Shinichi |
| Middle name | |
| Last name | Sakura |
Organization
Shimane University
Division name
Operation department
Zip code
693-8501
Address
89-1 Ennyacho, Izumo-city, Shimane, Japan
TEL
81-853-20-2295
ssakura@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | Shinichi |
| Middle name | |
| Last name | Sakura |
Organization
Shimane University
Division name
Operation department
Zip code
693-8501
Address
89-1 Ennyacho, Izumo-city, Shimane, Japan
TEL
81-853-20-2295
Homepage URL
ssakura@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University
Institute
Department
Personal name
Funding Source
Organization
none
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
Shimane University Hospital, Clinical Trial Review Board
Address
89-1 Enya-cho, Izumo-shi, Shimane, Japan
Tel
0853-20-2515
kenkyu@med.shimane-u.ac.jp
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
| 2018 | Year | 04 | Month | 17 | 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
50
Results
We observed the spread of injectate under thoracoscopy in 10 patients for each approach to continous thoracic paravertebral block (intercostal transverse in-plane approach, transverse process sagittal out-of-plane approach, paralaminar in-plane approach). The median (range) number of intercostal levels with the spread of injectate was 1.5 (1-4), 3 (1-4) and 3 (1-6) with IC, TS and PL approaches, respectively.
Results date posted
| 2020 | Year | 03 | Month | 13 | Day |
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
| 2018 | Year | 04 | Month | 10 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 10 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 16 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study was conducted to observe the distribution of injectate administered through a catheter inserted by performing ultrasound-guided thoracic paravertebral block (TPVB) for video assisted thoracoscopic surgery.
Management information
Registered date
| 2018 | Year | 04 | Month | 16 | Day |
Last modified on
| 2020 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036796
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
