UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	prospective randdomized study comparing the analgesic efficacy of ultrasound-guided quadratus lumborum block and local anesthetic infiltration for laparoscopic appendectomy
Title of the study (Brief title)	prospective randdomized study comparing the analgesic efficacy of ultrasound-guided quadratus lumborum block and local anesthetic infiltration for laparoscopic appendectomy
Region	Japan

Condition
Condition	patients who undergoing laparoscopic appendectomy
Classification by specialty	Gastrointestinal surgery Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	comparing the analgesic efficacy of ultrasound guided quadratus lumborum block and local anesthetic infiltration
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	duration of rescue dose
Key secondary outcomes	visual analog scale(0, 24h) QOR40

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	YES
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	local anesthetic infiltration
Interventions/Control_2	ultrasound-guided quadratus lumborum block
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	100 years-old >=
Gender	Male and Female
Key inclusion criteria	patients undergoing laparoscopic appendectomy
Key exclusion criteria	patients who refuse sepsisshock
Target sample size	40

Research contact person
Name of lead principal investigator	Manabu Yoshimura
Organization	Japan Community Healthcare Organization Tokuyama Central Hospital
Division name	Anesthesiology
Address	Kodacyo 1-1 Shunan 745-8522, Japan
TEL	0834-22-4411
Email	manabu-ygc@umin.ac.jp

Public contact
Name of contact person	Manabu Yoshimura
Organization	Japan Community Healthcare Organization Tokuyama Central Hospital
Division name	Anesthesiology
Address	Kodacyo 1-1 Shunan 745-8522, Japan
TEL	0834-22-4411
Homepage URL
Email	manabu-ygc@umin.ac.jp

Sponsor
Institute	Japan Community Healthcare Organization Tokuyama 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	Japan Community Healthcare Organization Tokuyama Central Hospital
Organization
Division
Category of Funding Organization	Self funding
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	2016 Year 04 Month 11 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2016 Year 04 Month 11 Day
Anticipated trial start date	2016 Year 04 Month 11 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	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 04 Month 11 Day
Last modified on	2016 Year 04 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025221