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Name
UMIN ID

Recruitment status
Unique ID issued by UMIN UMIN000024235
Receipt No. 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

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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
Institute Department of Anesthesiology, Nagano Children's Hospital
Institute
Department

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
URL(English) 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


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