UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Ultrasound-guided quadratus lumborum block for laparoscopic gynecological surgery :a randomized controlled trial
Title of the study (Brief title)	Efficacy of ultrasound-guided quadratus lumborum block for laparoscopic gynecological surgery
Region	Japan

Condition
Condition	myometrium adenomyosis of uterus gynecological benign tumor
Classification by specialty	Obsterics and gynecology Anesthesiology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Ultrasound-guided quadratus lumborum block (USG-QLB) could be provided visceral analgesia due to sympathetic nerve block, but most suitable injection point is still unknown. We performed two different approaches of USG-QLB for gynecological laparoscopic surgery and examined their efficacy and quality of recovery.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	postoperative fentanyl consumption the Quality of Recovery-40 (QoR-40) questionnaire at 24h after surgery Visual analog scale at a cough
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine Device,equipment Maneuver
Interventions/Control_1	Drug injection point is posterior side of quadratus lumborum
Interventions/Control_2	Drug injection point is antero-lateral side of quadratus lumborum
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	85 years-old >=
Gender	Female
Key inclusion criteria	ASA-PS status 1 to 2
Key exclusion criteria	Allergy to local anesthetics, coagulation disorders over 1.2 of PT-INR
Target sample size	60

Research contact person
Name of lead principal investigator	Taro Fujitani
Organization	Ehime Prefectural Central Hospital
Division name	Department of anesthesiology and critical care
Address	83 Kasuga-cho Matsuyama-city, Ehime 790-0024
TEL	089-947-1111
Email	ytaketa@juntendo.ac.jp

Public contact
Name of contact person	Yasuko Taketa
Organization	Ehime Prefectural Central Hospital
Division name	Department of anesthesiology and critical care
Address	83 Kasuga-cho Matsuyama-city, Ehime 790-0024
TEL	+81-89-947-1111
Homepage URL
Email	ytaketa@juntendo.ac.jp

Sponsor
Institute	Ehime Prefectural Central Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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	2014 Year 09 Month 30 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 09 Month 29 Day
Anticipated trial start date	2014 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 09 Month 29 Day
Last modified on	2016 Year 07 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017765