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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000017829
Receipt No. R000019529
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
Date of disclosure of the study information 2015/06/06
Last modified on 2015/06/06

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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
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 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
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 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
Date trial data considered complete
Date analysis concluded

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
Registered date File name

Research case data
Registered date File name


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