UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010146 |
|---|---|
| Receipt number | R000011883 |
| Scientific Title | Usefulness of ultrasound guided rectus sheath block on surgery of Laparoscopic percutaneous extraperitoneal closure (LPEC) |
| Date of disclosure of the study information | 2013/03/04 |
| Last modified on | 2015/03/04 15:10:30 |
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Basic information
Public title
Usefulness of ultrasound guided rectus sheath block on surgery of Laparoscopic percutaneous extraperitoneal closure (LPEC)
Acronym
Usefulness of ultrasound guided rectus sheath block on surgery of LPEC
Scientific Title
Usefulness of ultrasound guided rectus sheath block on surgery of Laparoscopic percutaneous extraperitoneal closure (LPEC)
Scientific Title:Acronym
Usefulness of ultrasound guided rectus sheath block on surgery of LPEC
Region
| Japan |
Condition
Condition
inguinal hernia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the analgesic effect and influence of emergence agitation of ultrasound guided rectus sheath block on surgery of LPEC.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The Pediatric Anesthesia Emergence Delirium Scale, The Behavioral Observational Pain Scale and the duration of time between end of surgery and first use of analgesic after surgery
Key secondary outcomes
Blood pressure,Heart rate,Duration of anaesthesia,Duration of surgery,Amount of Sevoflurane and fentanyl,Duration of time between end of suegery and extubation
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
General anesthesia
Interventions/Control_2
Gneral anesthesia with Rectus Sheath Block
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
| 15 | years-old | > |
Gender
Male and Female
Key inclusion criteria
ASA1-2
1-15 years of age
Key exclusion criteria
emergency operation
patient with disorders in central nervous system
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mio Yositake |
Organization
Kyusyu Medical Center
Division name
Department of Anesthesiology
Zip code
Address
1-8-1 Jigyouhama,Tyuoku,Fukuoka810-8563,Japan
TEL
0928520700
mimoringofarm@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mio Yoshitake |
Organization
Kitakyusyu Municipal Medical Center
Division name
Department of Anesthesiology
Zip code
Address
2-1-1 Bashyaku,Kokurakitaku,Kitakyusyu802-0077,Japan
TEL
0935411831
Homepage URL
mimoringofarm@yahoo.co.jp
Sponsor or person
Institute
Kitakyusyu Municipal Medical Center
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
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 03 | 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
Completed
Date of protocol fixation
| 2013 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 03 | Month | 06 | Day |
Last follow-up date
| 2014 | Year | 08 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 03 | Month | 01 | Day |
Last modified on
| 2015 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011883
| Research Plan | |
|---|---|
| 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 |
