UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042702 |
|---|---|
| Receipt number | R000048734 |
| Scientific Title | Optimal levobupivacaine concentration for ultrasound-guided rectus sheath block in pediatric patients |
| Date of disclosure of the study information | 2020/12/09 |
| Last modified on | 2023/12/23 13:27:16 |
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Basic information
Public title
Optimal levobupivacaine concentration for ultrasound-guided rectus sheath block in pediatric patients
Acronym
Optimal levobupivacaine concentration for ultrasound-guided rectus sheath block in pediatric patients
Scientific Title
Optimal levobupivacaine concentration for ultrasound-guided rectus sheath block in pediatric patients
Scientific Title:Acronym
Optimal levobupivacaine concentration for ultrasound-guided rectus sheath block in pediatric patients
Region
| Japan |
Condition
Condition
inguinal hernia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to determine the 50% effective (minimum) and the 95% effective (optimum) local analgesic dose of levobupivacaine for ultrasound guided rectus sheath block in children anesthetized with 2% sevoflurane.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Analgesic effect at skin incision
Key secondary outcomes
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 | months-old | <= |
Age-upper limit
| 10 | years-old | > |
Gender
Male and Female
Key inclusion criteria
children scheduled for surgery to be placed a skin incision in the navel
Key exclusion criteria
Patients with contraindications to RSB, a history of allergy to the study drug, weighing more than 3 mg/kg of levobupivacaine dose to be administered, or parental refusal were excluded from the study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yoshiyuki |
| Middle name | |
| Last name | Hiramoto |
Organization
University of Tsukuba
Division name
Department of Anesthesiology
Zip code
305-8575
Address
Amakubo 2-1-1, Tsukuba City, Ibaraki 305-8575, Japan
TEL
029-853-7668
hiramot@gmail.com
Public contact
Name of contact person
| 1st name | Yoshiyuki |
| Middle name | |
| Last name | Hiramoto |
Organization
University of Tsukuba
Division name
Department of Anesthesiology
Zip code
305-8575
Address
Amakubo 2-1-1, Tsukuba City, Ibaraki 305-8575, Japan
TEL
029-853-7668
Homepage URL
hiramot@gmail.com
Sponsor or person
Institute
University of Tsukuba Hospital
Institute
Department
Personal name
Funding Source
Organization
University of Tsukuba 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
University of Tsukuba Hospital
Address
Amakubo 2-1-1, Tsukuba City, Ibaraki 305-8575, Japan
Tel
029-853-7668
hiramot@gmail.com
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 | 12 | Month | 09 | 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
23
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
Main results already published
Date of protocol fixation
| 2013 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2006 | Year | 09 | Month | 21 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 12 | Month | 31 | Day |
Other
Other related information
Obsavation of analgesic effect of rectus sheath block at skin incision
Management information
Registered date
| 2020 | Year | 12 | Month | 09 | Day |
Last modified on
| 2023 | Year | 12 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048734
