UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of patient controlled epidural analgesia with automated mandatory boluses on post-operative pain in children undergoing the Nuss procedure for pectus excavatum
Title of the study (Brief title)	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	Seiki Abe
Organization	Nagano Children's Hospital
Division name	Department of Anesthesiology
Address	3100 Toyoshina, Nagano, JAPAN
TEL	0263736700
Email	seiki0623@yahoo.co.jp

Public contact
Name of contact person	Yuko Tanomogi
Organization	Shinshu University School of Medicine
Division name	Department of Anesthesiology and Resuscitology
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)

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

Progress
Recruitment status	Recruiting
Date of protocol fixation	2016 Year 07 Month 26 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027906