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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000032855
Receipt No. R000037377
Official scientific title of the study 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 2018/06/03

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Basic information
Official scientific title of the study postoperative analgesic effect between ultrasound-guided regional anesthesia for abdominal wall and local anethetics infiltration
Title of the study (Brief title) 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 Ikuyo Shinagawa
Organization Ehime prefectural central hospital
Division name Department of anesthesia
Address 83 Kasuga-cho Matsuyama-city, Ehime
TEL 089-947-1111
Email kubota0210@yahoo.co.jp

Public contact
Name of contact person Ikuyo Shinagawa
Organization Ehime prefectural central hospital
Division name Department of anesthesia
Address 83 Kasuga-cho Matsuyama-city, Ehime
TEL 089-947-1111
Homepage URL
Email kubota0210@yahoo.co.jp

Sponsor
Institute Ehime prefectural central hospital
Institute
Department

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)

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

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2018 Year 05 Month 15 Day
Anticipated trial start date
2018 Year 05 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
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
2018 Year 06 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037377

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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