UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021020 |
|---|---|
| Receipt number | R000024028 |
| Scientific Title | Pressure measurement of needle tip while performing ultrasound-guided thoracic paravertebral block |
| Date of disclosure of the study information | 2016/02/15 |
| Last modified on | 2017/05/12 07:23:34 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Pressure measurement of needle tip while performing ultrasound-guided thoracic paravertebral block
Acronym
Needle tip pressure measurement in thoracic paravertebral block
Scientific Title
Pressure measurement of needle tip while performing ultrasound-guided thoracic paravertebral block
Scientific Title:Acronym
Needle tip pressure measurement in thoracic paravertebral block
Region
| Japan |
Condition
Condition
Patients who undergo elective thoracic surgery under unilateral thoracotomy with paravertebral catheter insertion
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To show the pressure differense between intercostal muscle and paravertebral space as to indicate successful block when performing ultrasound-guided thoracic paravertebral block with intercostal transverse parallel approach.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Needle tip pressure difference when it places in intercostal muscle and paravertebral space
Key secondary outcomes
Factors which affect the pressure difference
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adult patients who undergo elective thoracic surgery under unilateral thoracotomy and to whom paravertebral catheter insertion was planned
Key exclusion criteria
Patients who did not or could not sign the written informed consent by themselves
In case the anesthesiologist who was not related to the study judged that the needle tip was not situated appropriately in the intercostal space or paravertebral spac in saved ultrasound image at the pressure measurement
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenta Okitsu |
Organization
Osaka university graduate school of medicine
Division name
Department of anesthesiology and intensive care medicine
Zip code
Address
Yamadaoka 2-2, Suita, Osaka
TEL
+81668793133
kokitsu@anes.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenta Okitsu |
Organization
Osaka university graduate school of medicine
Division name
Department of anesthesiology and intensive care medicine
Zip code
Address
Yamadaoka 2-2, Suita, Osaka
TEL
+81668793133
Homepage URL
kokitsu@anes.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of anesthesiology and intensive care medicine, Osaka university graduate school of medicine
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
大阪大学医学部附属病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | Month | 15 | 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
| 2016 | Year | 01 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 15 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2017 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2017 | Year | 06 | Month | 30 | Day |
Other
Other related information
This study includes all the patients undergoing thoracic or abdominal surgery under general anesthesia in Osaka University Hospital between 15th Feb 2016 and 31th Mar 2017 who fit for the study criteria. There is no group division. This is a prospective observational study which is aimed to reveal the change of the needle tip pressure when it is advanced to paravertebral space from intercostal muscle in performing thoracic paravertebral block.
Management information
Registered date
| 2016 | Year | 02 | Month | 14 | Day |
Last modified on
| 2017 | Year | 05 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024028
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
