UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024235
Receipt number R000027906
Scientific Title Effects of patient controlled epidural analgesia with automated mandatory boluses on post-operative pain in children undergoing the Nuss procedure for pectus excavatum
Date of disclosure of the study information 2016/10/30
Last modified on 2016/09/30 15:19:16

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Basic information

Public title

Effects of patient controlled epidural analgesia with automated mandatory boluses on post-operative pain in children undergoing the Nuss procedure for pectus excavatum

Acronym

Effects of patient controlled epidural analgesia with automated mandatory boluses on post-operative pain in children undergoing the Nuss procedure for pectus excavatum

Scientific Title

Effects of patient controlled epidural analgesia with automated mandatory boluses on post-operative pain in children undergoing the Nuss procedure for pectus excavatum

Scientific Title:Acronym

Effects of patient controlled epidural analgesia with automated mandatory boluses on post-operative pain in children undergoing the Nuss procedure for pectus excavatum

Region

Japan


Condition

Condition

pectus excavatum

Classification by specialty

Anesthesiology Child

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to investigate the effect of patient controlled epidural analgesia with automated mandatory boluses on post-operative pain in children undergoing the Nuss procedure for pectus excavatum.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The primary outcome of this study is the degree of sore throat assessed by using Numerical Rating Scale.

Key secondary outcomes

The secondary outcomes of this study are the time weighted mean hourly consumption of ropivacaine, satisfaction sores of patients, satisfaction scores of nurses, incidence of the side effects, etc.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

patient controlled epidural analgesia with automated mandatory boluses on post-operative pain

Interventions/Control_2

patient controlled epidural analgesia with basal infusions on post-operative pain

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

8 years-old <=

Age-upper limit

30 years-old >=

Gender

Male and Female

Key inclusion criteria

Patients (ASA physical status I or II) who are older than 8 years old, who undergo Nuss procedure under general anesthesia and epidural anesthesia.

Key exclusion criteria

Patients who was not able to be placed epidural catheter, patients whose epidural catheter were displaced within 96hours after operation.

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Seiki Abe

Organization

Nagano Children's Hospital

Division name

Department of Anesthesiology

Zip code


Address

3100 Toyoshina, Nagano, JAPAN

TEL

0263736700

Email

seiki0623@yahoo.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yuko Tanomogi

Organization

Shinshu University School of Medicine

Division name

Department of Anesthesiology and Resuscitology

Zip code


Address

3-1-1 Asahi, Matsumoto, Nagano, Japan

TEL

0263372670

Homepage URL


Email

y_matsuoka@shinshu-u.ac.jp


Sponsor or person

Institute

Department of Anesthesiology, Nagano Children's Hospital

Institute

Department

Personal name



Funding Source

Organization

Department of Anesthesiology, Nagano Children's Hospital

Organization

Division

Category of Funding Organization

Local Government

Nationality of Funding Organization



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



Other administrative information

Date of disclosure of the study information

2016 Year 10 Month 30 Day


Related information

URL releasing protocol


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

Date of protocol fixation

2016 Year 07 Month 26 Day

Date of IRB


Anticipated trial start date

2016 Year 07 Month 26 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 09 Month 30 Day

Last modified on

2016 Year 09 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027906


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name