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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000030912
Receipt No. R000035297
Scientific Title Analgesic effects and dermatomal spread of blockade after ultrasound-guided quadratus lumborum block: a prospective, observational study in patients after total laparoscopic hysterectomy
Date of disclosure of the study information 2018/01/24
Last modified on 2019/05/05

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Basic information
Public title Analgesic effects and dermatomal spread of blockade after ultrasound-guided quadratus lumborum block: a prospective, observational study in patients after total laparoscopic hysterectomy
Acronym Analgesic effects and dermatomal spread of blockade after ultrasound-guided quadratus lumborum block: a prospective, observational study in patients after total laparoscopic hysterectomy
Scientific Title Analgesic effects and dermatomal spread of blockade after ultrasound-guided quadratus lumborum block: a prospective, observational study in patients after total laparoscopic hysterectomy
Scientific Title:Acronym Analgesic effects and dermatomal spread of blockade after ultrasound-guided quadratus lumborum block: a prospective, observational study in patients after total laparoscopic hysterectomy
Region
Japan

Condition
Condition Total laparoscopic hysterectomy
Classification by specialty
Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To observe the analgesic effects and dermatomal spread after quadratus lumborum block in patients after total laparoscopic hysterectomy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Visual analogue pain scale at 24 hour after block
Key secondary outcomes postoperative opioid and other analgesic consumption
Dermatomal sensory spread
postoperative nausea and vomitting
complication related block
concentration and volume of local anesthetic for quadratus lumborum block

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

Not applicable
Gender Female
Key inclusion criteria Scheduled for total laparoscopic hysterectomy
American Society of Anesthesiologists physical status 1~3
Written informed concent for the study
Key exclusion criteria Allergy to study medication
Preoperative use of opioids and steroids
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Shinichi
Middle name
Last name Sakura
Organization Shimane University
Division name Operation department
Zip code 693-8501
Address 89-1 Ennyacho, Izumo-city, Shimane, Japan
TEL 81-853-20-2295
Email ssakura@med.shimane-u.ac.jp

Public contact
Name of contact person
1st name Shinichi
Middle name
Last name Sakura
Organization Shimane University
Division name Operation department
Zip code 693-8501
Address 89-1 Ennyacho, Izumo-city, Shimane, Japan
TEL 81-853-20-2295
Homepage URL
Email ssakura@med.shimane-u.ac.jp

Sponsor
Institute Shimane University Faculty of Medicine, Department of Anesthesiology
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 Shimane University Hospital, Clinical Trial Review Board
Address 89-1 Enya-cho, Izumo-shi, Shimane, Japan
Tel 0853-20-2515
Email kenkyu@med.shimane-u.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
2018 Year 01 Month 24 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
No significant difference was observed in postoperative pain scores, demands for analgesics, sensory blockade between the two groups of patients who received quadratuslumborum block using 20 ml of 0.375% levobupivacaine and 40 ml of 0.1875% levobupivacaine.
Results date posted
2019 Year 05 Month 05 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 No longer recruiting
Date of protocol fixation
2018 Year 01 Month 11 Day
Date of IRB
2018 Year 01 Month 11 Day
Anticipated trial start date
2018 Year 01 Month 20 Day
Last follow-up date
2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We are going to prospectivily observe the analgesic effect and the dermatomal spread after quadratus lumborum block.

Management information
Registered date
2018 Year 01 Month 20 Day
Last modified on
2019 Year 05 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035297

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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