UMIN-CTR Clinical Trial

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 and spread of cutaneous sensory blockade after different concentration and volume of local anesthetics used for quadratus lumborum block.
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	Completed
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 08 Month 09 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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