UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032855 |
|---|---|
| Receipt number | R000037377 |
| Scientific Title | postoperative analgesic effect between ultrasound-guided regional anesthesia for abdominal wall and local anethetics infiltration |
| Date of disclosure of the study information | 2018/06/04 |
| Last modified on | 2023/06/07 15:33:33 |
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Basic information
Public title
postoperative analgesic effect between ultrasound-guided regional anesthesia for abdominal wall and local anethetics infiltration
Acronym
postoperatibve analgesic effect in Pediatric laparoscopic perctaneous extraperitoneal closure
Scientific Title
postoperative analgesic effect between ultrasound-guided regional anesthesia for abdominal wall and local anethetics infiltration
Scientific Title:Acronym
postoperatibve analgesic effect in Pediatric laparoscopic perctaneous extraperitoneal closure
Region
| Japan |
Condition
Condition
inguinal hernia
Classification by specialty
| Surgery in general | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
we study postoperative analgesia between ultrasound-guided regional anesthesia for abdominal wall and local anesthetic infiltration in pediatric laparoscopic perctaneous extraperitoneal closure.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
postoperative pain
Key secondary outcomes
postoperative nausea and vomiting.
postoperative first analgesic administration time
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
| 12 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
ASA1-2
6-12years of age
Key exclusion criteria
Patients with
1. bleeding tendency or coagulation disorder
2. American Society of Anesthesiologists Physical Status III, IV or V.
3. disorders in central or peripheral nervous system
Target sample size
42
Research contact person
Name of lead principal investigator
| 1st name | Ikuyo |
| Middle name | |
| Last name | Shinagawa |
Organization
Ehime prefectural central hospital
Division name
Department of anesthesia
Zip code
790-0024
Address
83 Kasuga-cho Matsuyama-city, Ehime
TEL
089-947-1111
kubota0210@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Ikuyo |
| Middle name | |
| Last name | Shinagawa |
Organization
Ehime prefectural central hospital
Division name
Department of anesthesia
Zip code
790-0024
Address
83 Kasuga-cho Matsuyama-city, Ehime
TEL
089-947-1111
Homepage URL
kubota0210@yahoo.co.jp
Sponsor or person
Institute
Ehime prefectural central hospital
Institute
Department
Personal name
Funding Source
Organization
Ehime prefectural central hospital
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
Ehime Prefectural Central Hospital
Address
83 banchi,Kasuga,Matuyama,Ehime
Tel
089-947-1111
kubota0210@yahoo.co.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 | 06 | 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
42
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
| 2018 | Year | 05 | Month | 15 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 15 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 15 | Day |
Last follow-up date
| 2020 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The pediatric patients who underwent LPEC in our hospital between May 2015 and March 2018 and fit selection criteria
Management information
Registered date
| 2018 | Year | 06 | Month | 03 | Day |
Last modified on
| 2023 | Year | 06 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037377
| Research Plan | |
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| 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 |
