UMIN-CTR Clinical Trial

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

inguinal hernia

Classification by specialty

Anesthesiology

Child

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

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

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

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

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

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

Institute

Tokyo Metropolitan Children's Medical Center

Institute

Department

Personal name

Organization

Tokyo Metropolitan Children's Medical Center

Organization

Division

Category of Funding Organization

Local Government

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

東京都立小児総合医療センター

Date of disclosure of the study information

2015

Year

06

Month

06

Day

URL releasing protocol

http://www.byouin.metro.tokyo.jp/shouni/tiken/rinnshou_shounin.html

Publication of results

Unpublished

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

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 related information

Registered date

2015

Year

06

Month

06

Day

Last modified on

2015

Year

06

Month

06

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019529