UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021662 |
|---|---|
| Receipt number | R000024813 |
| Scientific Title | Analgesic effects of quadratus lumborum block and transversus abdominis plane block in patients undergoing gynecologic surgery |
| Date of disclosure of the study information | 2016/03/29 |
| Last modified on | 2019/07/29 22:29:47 |
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Basic information
Public title
Analgesic effects of quadratus lumborum block and transversus abdominis plane block in patients undergoing gynecologic surgery
Acronym
Analgesic effects of quadratus lumborum block and transversus abdominis plane block(QLB&TAP)
Scientific Title
Analgesic effects of quadratus lumborum block and transversus abdominis plane block in patients undergoing gynecologic surgery
Scientific Title:Acronym
Analgesic effects of quadratus lumborum block and transversus abdominis plane block(QLB&TAP)
Region
| Japan |
Condition
Condition
Gynecological laparoscopic surgery
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Prospective observation of analgesic effects of quadratus lumborum block and transversus abdominis plane block in patients undergoing gynecological laparoscopic surgery
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sensory blockade
Key secondary outcomes
Visual Analogue Scale
Fentanyl requirement
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Female
Key inclusion criteria
1)Scheduled operation of gynecology
2)ASA PS1-2
3)Between 20 years old and 70 years old
4)Written informed concent
Key exclusion criteria
1)Diabetic peripheral neuropathy
2)Use of steriod
3)Allergy of study medicine
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinichi Sakura |
Organization
Shimane Universty School of Medicine
Division name
Surgical Center, Shimane University Hospital
Zip code
Address
89-1, Enya-cho, Izumo City, Shimane
TEL
81-853-20-2295
ssakura@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Minori Wada |
Organization
Shimane Universty School of Medicine
Division name
Department of Anesthesiology
Zip code
Address
89-1, Enya-cho, Izumo City, Shimane
TEL
81-853-20-2295
Homepage URL
minoriwada0607@yahoo.co.jp
Sponsor or person
Institute
Shimane Universty Hospital, Shimane University School of Medicine
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
島根大学医学部附属病院(島根県)
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 03 | 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
40
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
| 2016 | Year | 03 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | Month | 28 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Between March 29,2016 and September 30,2017
This study includes all patient matched selective criteria between 29 March 2016 and 30 september 2017.
Analgesic effects of quadratus lumborum block and transversus abdominis plane block in patients undergoing gynecologic surgery are evaluated.
The results are retrospectively compared .
VAS
Loss of pain and cold
Use of fentanyl and medicine
Nausea and vomiting
Management information
Registered date
| 2016 | Year | 03 | Month | 29 | Day |
Last modified on
| 2019 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024813
