UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041246 |
|---|---|
| Receipt number | R000047094 |
| Scientific Title | Efficacy of preemptive analgesia with combination of transversus thoracis muscle plane block and rectus sheath block in pediatric cardiac surgery: a retrospective study |
| Date of disclosure of the study information | 2020/08/15 |
| Last modified on | 2020/07/29 14:19:47 |
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Basic information
Public title
Efficacy of preemptive analgesia with combination of transversus thoracis muscle plane block and rectus sheath block in pediatric cardiac surgery: a retrospective study
Acronym
Retrospective evaluation of transversus thoracis muscle plane block and rectus sheath block in pediatric cardiac surgery
Scientific Title
Efficacy of preemptive analgesia with combination of transversus thoracis muscle plane block and rectus sheath block in pediatric cardiac surgery: a retrospective study
Scientific Title:Acronym
Retrospective evaluation of transversus thoracis muscle plane block and rectus sheath block in pediatric cardiac surgery
Region
| Japan |
Condition
Condition
congenital heart disease
Classification by specialty
| Vascular surgery | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of transversus thoracis muscle plane block and rectus sheath block in pediatric cardiac surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time to extubation
Key secondary outcomes
Fentanyl effect-site concentration at extubation, fentanyl consumption until extubation, intraoperative remifentanil consumption, number of drug administration for sedation, number of reintubation, number of adverse event
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
| Not applicable |
Age-upper limit
| 15 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patients who underwent open cardiac surgery at Niigata University Medical and Dental Hospital, and did not express obvious refusal for the research use of the one's medical records
Key exclusion criteria
The patients who did not agree for research use of one's medical records
The patients whose medical records were incomplete
The patients who was extubated after 6 hours of admission to ICU
The patients who wasn't used fentanyl for pain control
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Keiichiro |
| Middle name | |
| Last name | Matsuda |
Organization
Niigata University Medical and Dental Hospital
Division name
Division of Anesthesiology
Zip code
951-8510
Address
1-754 Asahimachi-dori, Chuo ward, Niigata 950-8570, Japan
TEL
025-227-2328
matsuk19@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Keiichiro |
| Middle name | |
| Last name | Matsuda |
Organization
Niigata University Medical and Dental Hospital
Division name
Division of Anesthesiology
Zip code
951-8510
Address
1-754 Asahimachi-dori, Chuo ward, Niigata 950-8570, Japan
TEL
025-227-2328
Homepage URL
matsuk19@med.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University Medical and Dental Hospital
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
Niigata University Medical and Dental Hospital
Address
1-754 Asahimachi-dori, Chuo ward, Niigata 950-8570, Japan
Tel
025-227-2328
matsuk19@med.niigata-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
| 2020 | Year | 08 | 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
76
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
| 2020 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 17 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
retrospective study
Management information
Registered date
| 2020 | Year | 07 | Month | 29 | Day |
Last modified on
| 2020 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047094
