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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010146
Receipt No. 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

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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
Email 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
Email mimoringofarm@yahoo.co.jp

Sponsor
Institute Kitakyusyu Municipal Medical Center
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011883

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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