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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000032226
Receipt No. R000034783
Scientific Title Intramuscular quadratus lumborum block for postoperative pain after total laparoscopic hysterectomy. A randomized controlled trial.
Date of disclosure of the study information 2018/04/13
Last modified on 2018/10/14

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Basic information
Public title Intramuscular quadratus lumborum block for postoperative pain after total laparoscopic hysterectomy. A randomized controlled trial.
Acronym Intramuscular quadratus lumborum block after total laparoscopic hysterectomy.
Scientific Title Intramuscular quadratus lumborum block for postoperative pain after total laparoscopic hysterectomy. A randomized controlled trial.
Scientific Title:Acronym Intramuscular quadratus lumborum block after total laparoscopic hysterectomy.
Region
Japan

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

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

Assessment
Primary outcomes opioid consumption after 24 hours after surgery
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Itervention
intramuscular quadratus lumblorum block(0.25% levobupivacain)
Interventions/Control_2 cotrol
intramuscular quadratus lumblorum block(saline)
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 total laparoscopic hysterectomy 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 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Fujimoto Hiroko
Organization Yokohama City University School of Medicine
Division name Department of Anesthesiology and Critical Care Medicine
Zip code
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
Middle name
Last name Hiroko Fujimoto
Organization Yokohama City University School of Medicine
Division name Department of Anesthesiology and Critical Care Medicine
Zip code
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
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

Other administrative information
Date of disclosure of the study information
2018 Year 04 Month 13 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 Terminated
Date of protocol fixation
2017 Year 12 Month 15 Day
Date of IRB
Anticipated trial start date
2018 Year 03 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
2018 Year 04 Month 13 Day
Last modified on
2018 Year 10 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034783

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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