UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008419 |
|---|---|
| Receipt number | R000009904 |
| Scientific Title | Analgesic effect of transversus abdominis plane block after inguinal hernia operation in children |
| Date of disclosure of the study information | 2012/08/01 |
| Last modified on | 2015/01/12 23:01:58 |
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Basic information
Public title
Analgesic effect of transversus abdominis plane block after inguinal hernia operation in children
Acronym
Analgesic effect of transversus abdominis plane block after inguinal hernia operation in children
Scientific Title
Analgesic effect of transversus abdominis plane block after inguinal hernia operation in children
Scientific Title:Acronym
Analgesic effect of transversus abdominis plane block after inguinal hernia operation in children
Region
| Japan |
Condition
Condition
inguinal hernia
Classification by specialty
| Surgery in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the analgesic effect of transversus abdominis plane block in child undergoing surgery for inguinal hernia under Potts procedure and laparoscopic herniorrhaphy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postoperative pain
Key secondary outcomes
Requirement of postoperative analgesics
Occurrence of nausea and vomiting
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Transversus abdominis plane block in children undergoing Potts procedure
Interventions/Control_2
Epidural block in children undergoing Potts procedure
Interventions/Control_3
Transversus abdominis plane block in children undergoing laparoscopic herniorrhaphy
Interventions/Control_4
Paraumbilical block in children undergoing laparoscopic herniorrhaphy
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| 10 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Children undergoing radical operation for inguinal hernia under Potts precedure or laparoscopic herniorrhaphy
Key exclusion criteria
Patients with
1. bleeding tendency or coagulation disorder
2. American Society of Anesthesiologists Physical Status III, IV or V.
3. disorders in central or peripheral nervous system
4. difficulty in performing nerve block
5. past history of abnormal reaction to general or local anesthetics
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryu Okutani |
Organization
Osaka City General Hospital and Children's Hospital
Division name
Department of Anesthesiology
Zip code
Address
2-13-22 Miyakojima Hondori, Miyakojima-ku, Osaka 534-0021, Japan
TEL
81-6-6929-1221
ryuokutani0909@ybb.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryu Okutani |
Organization
Osaka City General Hospital and Children's Hospital
Division name
Department of Anesthesiology
Zip code
Address
2-13-22 Miyakojima Hondori, Miyakojima-ku, Osaka 534-0021, Japan
TEL
81-6-6929-1221
Homepage URL
ryuokutani0909@ybb.ne.jp
Sponsor or person
Institute
Osaka City General Hospital and Children's Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
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 | 07 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | Month | 15 | 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
| 2012 | Year | 07 | Month | 12 | Day |
Last modified on
| 2015 | Year | 01 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009904
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
