UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009271 |
|---|---|
| Receipt number | R000010889 |
| Scientific Title | The effectiveness of TAP block in gynecological surgery |
| Date of disclosure of the study information | 2012/12/01 |
| Last modified on | 2015/03/24 11:56:01 |
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Basic information
Public title
The effectiveness of TAP block in gynecological surgery
Acronym
The effectiveness of TAP block
Scientific Title
The effectiveness of TAP block in gynecological surgery
Scientific Title:Acronym
The effectiveness of TAP block
Region
| Japan |
Condition
Condition
Gynecological surgery performed under general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In gynecological abdominal surgery, combination of general anesthesia and epidural anesthesia is usually performed. The benefits of epidural anesthesia is greater, but sensory and motor deterioration, urinary retention, nausea is highly possibile. It is likely to occur PDPH, if you happen to accidentally puncture the epidural, also has a significant effect on the patient's QOL. There is no built-dominant effect on the TAP block, but the analgesic effect of the abdominal wall is good. Visceral dominant nerve is covered by general anesthesia. Possibility of epidural puncture is zero, TAP block enforcement can be almost certainly by using the echo. We examine the effect of analgesia and incidence of complications in lower abdominal gynecological surgery of benign disease, when using TAP block and epidural anesthesia in general anesthesia.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Analgesic effect of TAP block
Key secondary outcomes
Side effects of TAP block
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Use the TAP block rather than epidural anesthesia
Interventions/Control_2
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Anesthesia
Benign gynecological disease
Lower transverse incision
Key exclusion criteria
Malignancy
Myoma enucleation
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Ando |
Organization
Tokyo Metropolitan Otsuka Hospital
Division name
Anesthesiology
Zip code
Address
2-8-1 Minami Otsuka Toshima-ku Tokyo
TEL
03-3941-3211
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takeshi Ando |
Organization
Tokyo Metropolitan Otsuka Hospital
Division name
Anesthesiology
Zip code
Address
2-8-1 Minami Otsuka Toshima-ku
TEL
03-3941-3211
Homepage URL
Sponsor or person
Institute
Tokyo Metropolitan Otsuka 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 | 12 | 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 | 11 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 11 | Month | 06 | Day |
Last modified on
| 2015 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010889
