UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016350 |
|---|---|
| Receipt number | R000018982 |
| Scientific Title | Ultrasound-guided transversus abdominis plane block for laparoscopic gynecological surgery :a randomized controlled trial |
| Date of disclosure of the study information | 2015/01/27 |
| Last modified on | 2015/08/12 09:17:24 |
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Basic information
Public title
Ultrasound-guided transversus abdominis plane block for laparoscopic gynecological surgery :a randomized controlled trial
Acronym
Efficacy of ultrasound-guided transversus abdominis plane block for laparoscopic gynecological surgery
Scientific Title
Ultrasound-guided transversus abdominis plane block for laparoscopic gynecological surgery :a randomized controlled trial
Scientific Title:Acronym
Efficacy of ultrasound-guided transversus abdominis plane block for laparoscopic gynecological surgery
Region
| Japan |
Condition
Condition
myometrium
adenomyosis of uterus
gynecological benign tumor
Classification by specialty
| Obstetrics and Gynecology | Anesthesiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Posterior transversus abdominis plane block (posterior TAP block) has been considered as a useful block for lower abdominal postoperative analgesia, but in ultrasound-guided block, its efficacy and usability are still unknown. We prospectively compared the analgesic efficacy among posterior and lateral TAP block with control group in laparoscopic gynecological surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visual analog scale at a cough
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 | Device,equipment | Maneuver |
Interventions/Control_1
ultrasound-guided TAP block (lateral approach)
Interventions/Control_2
Ultrasound-guided TAP block (posterior approach)
Interventions/Control_3
TAP block is not performed
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
| 85 | years-old | >= |
Gender
Female
Key inclusion criteria
ASA-PS status 1 to 2
Key exclusion criteria
Allergy to local anesthetics, coagulation disorders over 1.2 of PT-INR
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Taro Fujitani |
Organization
Ehime Prefectural Central Hospital
Division name
Department of anesthesiology and critical care
Zip code
Address
83 Kasuga-cho Matsuyama-city, Ehime 790-0024
TEL
+81-89-947-1111
ytaketa@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuko Taketa |
Organization
Ehime Prefectural Central Hospital
Division name
Department of anesthesiology and clitical care
Zip code
Address
83 Kasuga-cho Matsuyama-city, Ehime 790-0024
TEL
+81-89-947-1111
Homepage URL
ytaketa@juntendo.ac.jp
Sponsor or person
Institute
Ehime Prefectural Central Hospital
Institute
Department
Personal name
Funding Source
Organization
Ehime Prefectural Central Hospital
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
| 2015 | Year | 01 | Month | 27 | 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
Main results already published
Date of protocol fixation
| 2013 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 09 | 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
| 2015 | Year | 01 | Month | 27 | Day |
Last modified on
| 2015 | Year | 08 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018982
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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