UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018833 |
|---|---|
| Receipt number | R000021784 |
| Scientific Title | The efficacy of postoperative paravertebral block with lamina technique in patients undergoing atrial septal defect closure with lateral thoracotomy. |
| Date of disclosure of the study information | 2015/08/27 |
| Last modified on | 2018/12/10 16:04:46 |
* 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
The efficacy of postoperative paravertebral block with lamina technique in patients undergoing atrial septal defect closure with lateral thoracotomy.
Acronym
The efficacy of lamina technique paravertebral block in ASD closure patients with lateral thoracotomy.
Scientific Title
The efficacy of postoperative paravertebral block with lamina technique in patients undergoing atrial septal defect closure with lateral thoracotomy.
Scientific Title:Acronym
The efficacy of lamina technique paravertebral block in ASD closure patients with lateral thoracotomy.
Region
| Japan |
Condition
Condition
Atrial septal defect
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Lateral thoracotomy induces severe postoperative pain. We elucidate the efficacy of paravertebral block in patinets undergoing ASD closure with lateral thoracotomy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Pain scale using Face scale and the number of rescue analgesics usage in postoperative 5 days.
Key secondary outcomes
The catheter removed day, postoperative nausea and vomiting, ICU stay day, days for discharged from hospital, incidence of adverse events
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
| 6 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
･Patients with American Society of Anesthesiologists - Physical States 1 or 2
･Patients who undergo atrial septal defect closure with lateral thoracotomy
Key exclusion criteria
･Emergency case
･The nonage whose protector did not approved study enrollment
･The patients with severe respiratory or cardiovascular disease
･The patients with severe malformations
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuko Nawa |
Organization
Hokkaido Medical Center for Child Health and Rehabilitation
Division name
Anesthesiology
Zip code
Address
1-240-6, Kanayama 1 jo, Teine-ku, Sapporo, Hokkaido, JAPAN
TEL
011-691-5696
yukonawa@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomohiro Chaki |
Organization
Sapporo Medical University School of Medicine
Division name
Anesthesiology
Zip code
Address
291, South 1, West 16, Chuo-ku, Sapporo, Hokkaido, JAPAN
TEL
011-611-2111
Homepage URL
chakitomohiro0728@yahoo.co.jp
Sponsor or person
Institute
Department of Anesthesiology, Sapporo Medical University 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
Department of Anesthesiology, Hokkaido Medical Center for Child Health and Rehabilitation
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
北海道立子ども総合医療療育センター
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 08 | Month | 27 | 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 | 08 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 08 | Month | 28 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We evaluate the degree of postoprative pain using face scale and the number of usage of rescue analgesics.
Management information
Registered date
| 2015 | Year | 08 | Month | 27 | Day |
Last modified on
| 2018 | Year | 12 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021784
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
