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
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
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
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
