UMIN-CTR Clinical Trial

Basic information
Public title	Randomized controlled study of postoperative analgesia of pediatric hernioplasty between one layer and two layers injection of ropivacaine to block ilioinguinal/iliohypogastric nerves
Acronym	RCT of postoperative analgesia of hernioplasty between one layer and two layers injection of ropivacaine to block II/IH in children
Scientific Title	Randomized controlled study of postoperative analgesia of pediatric hernioplasty between one layer and two layers injection of ropivacaine to block ilioinguinal/iliohypogastric nerves
Scientific Title:Acronym	RCT of postoperative analgesia of hernioplasty between one layer and two layers injection of ropivacaine to block II/IH in children
Region	Japan

Condition
Condition	inguinal hernia
Classification by specialty	Anesthesiology Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	A prospective study to evaluate both fascial planes (EOM/IOM and IOM/TOM) as injection sites of ropivacaine for postoperative analgesia in pediatric outpatients inguinal herniopasty
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The primary aim was to evaluate postoperative analgesia as the FLACC score at 45minutes after surgery and the requirement for other analgesics in recovery room and at home
Key secondary outcomes	1) the requirement for other analgesics in recovery room and at home within 24hours after surgery 2) evaluate the immediate effect of the II/IH nerve block on body movement at the incision site

Base
Study type

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	1.Term: From the induction of anesthesia to discharge, and following 24hours at home. 2.Dose: Total dose is given to one layer. 3.Times: Once
Interventions/Control_2	1.Term: From the induction of anesthesia to discharge, and following 24hours at home. 2.Dose: Total dose is same as control. The dose is divided into 2:1. 3.Times: Once
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 months-old <=
Age-upper limit	108 months-old >
Gender	Male and Female
Key inclusion criteria	1.Patients who undergo scheduled inguinal hernioplasty as outpatient. 2.ASA physical status 1 or 2. 3.Patients whose guardians agree with participation of the study and sign the agreement form.
Key exclusion criteria	1.Patients who have surgical or traumatic scars in abdominal wall. 2.Patients who undergo both sides hernioplasty in the same day 3.Patients who are not appropriate to receive surgery as out patients 4.Patients who are not appropriate for the study judged by the primary researcher
Target sample size	220

Research contact person
Name of lead principal investigator	1st name Middle name Last name Noriko Miyazawa
Organization	Tokyo Metropolitan Children's Medical Center
Division name	Anesthesiology
Zip code
Address	2-8-29 Musashidai Fuchu Tokyo, Japan
TEL	042-300-5111
Email	noriko_miyazawa@tmhp.jp

Public contact
Name of contact person	1st name Middle name Last name Noriko Miyazawa
Organization	Tokyo Metropolitan Children's Medical Center
Division name	Anesthesiology
Zip code
Address	2-8-29 Musashidai Fuchu Tokyo, Japan
TEL	042-300-5111
Homepage URL	http://www.byouin.metro.tokyo.jp/shouni/tiken/rinnshou_shounin.html
Email	noriko_miyazawa@tmhp.jp

Sponsor
Institute	Tokyo Metropolitan Children's Medical Center
Institute
Department

Funding Source
Organization	Tokyo Metropolitan Children's Medical Center
Organization
Division
Category of Funding Organization	Local Government
Nationality of Funding Organization	Japan

Other related organizations
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IRB Contact (For public release)
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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	東京都立小児総合医療センター

Other administrative information
Date of disclosure of the study information	2015 Year 06 Month 06 Day

Related information
URL releasing protocol	http://www.byouin.metro.tokyo.jp/shouni/tiken/rinnshou_shounin.html
Publication of results	Unpublished

Result
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Number of participants that the trial has enrolled
Results
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Results Delayed
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Baseline Characteristics
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Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2015 Year 02 Month 12 Day
Date of IRB
Anticipated trial start date	2015 Year 04 Month 01 Day
Last follow-up date	2016 Year 03 Month 31 Day
Date of closure to data entry
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Other
Other related information

Management information
Registered date	2015 Year 06 Month 06 Day
Last modified on	2015 Year 06 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019529

Research Plan
Registered date	File name

Research case data specifications
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Research case data
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