UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008586 |
|---|---|
| Receipt number | R000010086 |
| Scientific Title | The effect of ultrasound-guided ilioinguinal/iliohypogastric nerve block on the postoperative pain and emergence agitation in pediatric anesthesia for day-case open inguinal hernia repair. |
| Date of disclosure of the study information | 2012/08/01 |
| Last modified on | 2013/08/04 20:55:35 |
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Basic information
Public title
The effect of ultrasound-guided ilioinguinal/iliohypogastric nerve block on the postoperative pain and emergence agitation in pediatric anesthesia for day-case open inguinal hernia repair.
Acronym
The effect of ultrasound-guided ilioinguinal/iliohypogastric nerve block on the postoperative pain and emergence agitation for inguinal hernia repair.
Scientific Title
The effect of ultrasound-guided ilioinguinal/iliohypogastric nerve block on the postoperative pain and emergence agitation in pediatric anesthesia for day-case open inguinal hernia repair.
Scientific Title:Acronym
The effect of ultrasound-guided ilioinguinal/iliohypogastric nerve block on the postoperative pain and emergence agitation for inguinal hernia repair.
Region
| Japan |
Condition
Condition
pediatric anesthesia for day-case open inguinal hernia repair
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Recently, Ultrasound-guided ilioinguinal/iliohypogastric nerve block has shown usefulness in pediatric anesthesia for day-case open inguinal hernia repair. However, there are some reports that this block provides effective analgesia, it has not been reported that this block contributes to decrease the emergence agitation This prospective, randomized study tests the hypothesis that Ultrasound-guided ilioinguinal/iliohypogastric nerve block may provide analgesia and decrease the emergence agitation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Behavioral Observational Pain Scale(BOPS) and the Pediatric Anesthesia Emergence Delirium (PAED) Scaleat the three points(30min, an hour, four hours after awake intubation)
Key secondary outcomes
Blood pressure,Heart rate,Respiratory rate,Amount of sevoflurane,Side effect
Duration of anaesthesia,Duration of surgery,Time to emergence after surgery
Further analgesic
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
follow up period a year,block group 20 cases,medication 0.5%ropivacaine0.2ml/kg
Interventions/Control_2
follow up period a year,control group 20 cases
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
| 1 | years-old | <= |
Age-upper limit
| 6 | years-old | >= |
Gender
Male
Key inclusion criteria
1-6 years of age,male,ASA1-2
Key exclusion criteria
emergency operation,allergy to medicine
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ohashi Nobuko |
Organization
Niigata city general hospital
Division name
Department of Anesthesiology
Zip code
Address
Niigata city shumoku 463-7
TEL
025-281-5151
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ohashi Nobuko |
Organization
Niigata city general hospital
Division name
Department of Anesthesiology
Zip code
Address
TEL
025-281-5151
Homepage URL
Sponsor or person
Institute
Niigata city general hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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
| 2012 | Year | 08 | Month | 01 | 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
Completed
Date of protocol fixation
| 2012 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 08 | Month | 01 | Day |
Last modified on
| 2013 | Year | 08 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010086
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
