UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Ultrasound image of expansion of the epidural space in pediatric epidural analgesia
Title of the study (Brief title)	Uitrasound image of pediatric epidural space
Region	Japan

Condition
Condition	Patients recieved epidural analgesia during surgery
Classification by specialty	Pediatrics Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Annalysis of relationship between patient's demographics and the expansion of epidural space
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The relationship between patient's demographics and the expansion of epidural space
Key secondary outcomes	Success rate of clear observation of ultrasound image of epidural space

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment	Central registration

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	Recording ultrasound image during epidural drug infusion
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	0 years-old <=
Age-upper limit	12 years-old >=
Gender	Male and Female
Key inclusion criteria	Pediatric patients recieved epidural analgesia during surgery
Key exclusion criteria	Coagulation dysorder Vertebral Deformity Congenital heart disease Allegy of local anesthetics Preoperative neural symptom of extrimity Unstable respiratry condition or hemodynamics
Target sample size	100

Research contact person
Name of lead principal investigator	Yoshiki Nakajima
Organization	Hamamatsu University School of Medicine
Division name	Anesthesiology
Address	1-20-1 Handayama, Higashiku, Hamamatsu
TEL	053-435-2286
Email	nakayos@hama-med.ac.jp

Public contact
Name of contact person	Masahiro Yagihara
Organization	Hamamatsu University School of Medicine
Division name	Anesthesiology
Address	1-20-1 Handayama, Higashiku, Hamamatsu
TEL	053-435-2286
Homepage URL
Email	yagi@rj8.so-net.ne.jp

Sponsor
Institute	Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization	Hamamatsu University School of Medicine Department of Anesthesiology
Organization
Division
Category of Funding Organization	Other
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	2017 Year 05 Month 15 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 05 Month 01 Day
Anticipated trial start date	2017 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

Management information
Registered date	2017 Year 05 Month 04 Day
Last modified on	2017 Year 05 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031212