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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021662
Receipt No. 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

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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
Obsterics 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
Email 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
Email minoriwada0607@yahoo.co.jp

Sponsor
Institute Shimane Universty Hospital, Shimane University School of Medicine
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024813

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name
2019/07/29 Data.xlsx


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