UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004802 |
|---|---|
| Receipt number | 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 01:16:16 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
kohno_yumi@yahoo.co.jp
Sponsor or person
Institute
Higashiomiya 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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005718
