UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042347 |
|---|---|
| Receipt number | R000047904 |
| Scientific Title | Comparison of the analgesic efficacy of rectus sheath block and thoracoabdominal nerves through perichondrial approach block for laparoscopic percutaneous extraperitoneal closure in children |
| Date of disclosure of the study information | 2020/11/04 |
| Last modified on | 2020/11/04 17:25:30 |
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Basic information
Public title
Comparison of the analgesic efficacy of rectus sheath block and thoracoabdominal nerves through perichondrial approach block for laparoscopic percutaneous extraperitoneal closure in children
Acronym
Comparison of the analgesic efficacy of rectus sheath block and thoracoabdominal nerves through perichondrial approach block for laparoscopic percutaneous extraperitoneal closure in children
Scientific Title
Comparison of the analgesic efficacy of rectus sheath block and thoracoabdominal nerves through perichondrial approach block for laparoscopic percutaneous extraperitoneal closure in children
Scientific Title:Acronym
Comparison of the analgesic efficacy of rectus sheath block and thoracoabdominal nerves through perichondrial approach block for laparoscopic percutaneous extraperitoneal closure in children
Region
| Japan |
Condition
Condition
inguinal hernia
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison of thoracoabdominal nerves block through perichondrial approach (M-TAPA) and rectus sheath block for analgesia of laparoscopic ventral hernia repair in children.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
FLACC scale: Face, Legs, Activity, Cry, Consolability. State Behavioral Scale
Key secondary outcomes
Emergence agitation
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
| 1 | years-old | <= |
Age-upper limit
| 6 | years-old | >= |
Gender
Female
Key inclusion criteria
age: under 6 years old
patients undergoing general anesthesia for LPEC
Key exclusion criteria
ADHD
Patients judged inadequate to join the study by attending doctor
allergy to local anesthetics
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | JUN |
| Middle name | |
| Last name | YOSHINO |
Organization
St. Mary's Hospital
Division name
Department of Anesthesia
Zip code
8308543
Address
422 Tsubukuhonmachi Kurume city
TEL
0942-35-3322
j-yoshino@st-mary-med.or.jp
Public contact
Name of contact person
| 1st name | Yoshie |
| Middle name | |
| Last name | Naito |
Organization
St. Mary's Hospital
Division name
Department of
Zip code
8308543
Address
422 Tsubukuhonmachi Kurume City
TEL
0942-35-3322
Homepage URL
naito-yoshie@st-mary-med.or.jp
Sponsor or person
Institute
St. mary's Hospital
Department of Anesthesia
Institute
Department
Personal name
Funding Source
Organization
St. Mary's Hospital
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
St. Mary's Hospital
Address
422 tsubukuhonmachi ,Kurume City
Tel
0942-35-3322
naito-yoshie@st-mary-med.or.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 | 11 | Month | 04 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 12 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2020 | Year | 11 | Month | 04 | Day |
Last modified on
| 2020 | Year | 11 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047904
