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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004802
Receipt No. R000005718
Scientific Title Comparative study of Transversus Abdominis Plane Block and epidural block for lapaloscopic inguinal total extraperitoneal hernia repair under general anestesia
Date of disclosure of the study information 2010/12/29
Last modified on 2012/01/31

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Basic information
Public title Comparative study of Transversus Abdominis Plane Block and epidural block for lapaloscopic inguinal total extraperitoneal hernia repair under general anestesia
Acronym Comparative study concerning effective method of relieving pain for lapaloscopic inguinal total extraperitoneal hernia repair under general anestesia
Scientific Title Comparative study of Transversus Abdominis Plane Block and epidural block for lapaloscopic inguinal total extraperitoneal hernia repair under general anestesia
Scientific Title:Acronym Comparative study concerning effective method of relieving pain for lapaloscopic inguinal total extraperitoneal hernia repair under general anestesia
Region
Japan

Condition
Condition inguinal hernia
Classification by specialty
Surgery in general Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Epidural block and Transversus Abdominis Plane block are comparing evaluated as a method of relieving pain after laparoscopic total extraperitoneal inguinal hernia repair
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes VAS
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 general anesthesia
Interventions/Control_2 general anesthesia with Transversus Abdominis Plane block
Interventions/Control_3 general anesthesia with epidural block
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
20 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria ASA1-2
lapaloscopic total extraperitoneal inguinal hernia repair
Key exclusion criteria hepatic dysfunction
renal dysfunction
obesity
medicine allergy
cutaneous abnormality
open surgery
reoperation
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yumiko Kohno
Organization Higashiomiya general hospital
Division name Anestesiology
Zip code
Address 5-18,Higashiomiya,minuma-ku,Saitama city,Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Higashiomiya general hospital
Division name Anesthesiology
Zip code
Address
TEL
Homepage URL
Email kohno_yumi@yahoo.co.jp

Sponsor
Institute Higashiomiya 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 東大宮総合病院(埼玉県)

Other administrative information
Date of disclosure of the study information
2010 Year 12 Month 29 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
2010 Year 11 Month 16 Day
Date of IRB
Anticipated trial start date
2010 Year 12 Month 01 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
2010 Year 12 Month 28 Day
Last modified on
2012 Year 01 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005718

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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