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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024161
Receipt No. R000024693
Scientific Title Efficacy of quadratus lumborum block on postoperative quality of recovery after gynecological laparoscopic surgery A single center randomized controlled trial
Date of disclosure of the study information 2016/09/26
Last modified on 2020/01/06

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Basic information
Public title Efficacy of quadratus lumborum block on postoperative quality of recovery after gynecological laparoscopic surgery
A single center randomized controlled trial
Acronym Efficacy of quadratus lumborum block on postoperative quality of recovery after gynecological laparoscopic surgery
Scientific Title Efficacy of quadratus lumborum block on postoperative quality of recovery after gynecological laparoscopic surgery
A single center randomized controlled trial
Scientific Title:Acronym Efficacy of quadratus lumborum block on postoperative quality of recovery after gynecological laparoscopic surgery
Region
Japan

Condition
Condition Adults patients scheduled for gynecological laparoscopic surgery
Classification by specialty
Obsterics and gynecology Anesthesiology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the efficacy of quadratus lumborum block after gynecological laparoscopic surgery
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The quality of recovery-40 questionnaire(QOR40)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Quadratus lumborum block group
Interventions/Control_2 control group
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 ASA physical status 1 and 2 adult patients scheduled for gynecological laparoscopic surgery at Yokohama City University Hospital
Key exclusion criteria Patients with cognitive dysfunction, obesity(BMI>=35),renal dysfunction(eGFR<=50), drug allergy for NSAIDs,acetaminophen,local anesthetic, gastric ulcer
Pregnant or suspected pregnant patients
Pre-operative regular use of opioids or steroids
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Hiroko
Middle name
Last name Fujimoto
Organization Yokohama City University School of Medicine
Division name Department of Anesthesiology and Critical Care Medicine
Zip code 236-0004
Address 3-9 Fukuura, Kanazawa-ku,Yokohama-shi, Kanagawa-ken,236-0004, Japan.
TEL 0457872800
Email pochipochi_7@yahoo.co.jp

Public contact
Name of contact person
1st name Hiroko
Middle name
Last name Fujimoto
Organization Yokohama City University School of Medicine
Division name Department of Anesthesiology and Critical Care Medicine
Zip code 236-0004
Address 3-9 Fukuura, Kanazawa-ku,Yokohama-shi, Kanagawa-ken,236-0004, Japan.
TEL 0457872800
Homepage URL
Email pochipochi_7@yahoo.co.jp

Sponsor
Institute Yokohama City University School of Medicine. Department of Anesthesiology and Critical Care Medicine.
Institute
Department

Funding Source
Organization no
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 Yokohama City University School of Medicine
Address 3-9 Fukuura, Kanazawa-ku,Yokohama-shi, Kanagawa-ken,236-0004, Japan.
Tel 0457872800
Email onodera@yokohama-cu.ac.jp

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
2016 Year 09 Month 26 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled 60
Results The QLB did not improve the quality of recovery after gynecological laparoscopic surgery.
Results date posted
2020 Year 01 Month 06 Day
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 04 Month 01 Day
Date of IRB
2016 Year 02 Month 24 Day
Anticipated trial start date
2016 Year 04 Month 01 Day
Last follow-up date
2019 Year 02 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 09 Month 26 Day
Last modified on
2020 Year 01 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024693

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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