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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008586
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Niigata city general hospital
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010086

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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