UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The concentration of local anesthetics required for neural block under general anesthesia
Title of the study (Brief title)	The concentration of local anesthetics required for neural block under general anesthesia
Region	Japan

Condition
Condition	inguinal hernia surgery, undescended testes surgery, abdominal surgery, limb surgery
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To determine the 50% effective concentration (EC50) and the 95% effective concentration (EC95) of local anesthetics for neural block under general anesthesia.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	EC95 and EC50 of local anesthetics (levobupivacaine) for neural block (ultrasound-guided ilioinguinal/iliohypogastric nerve block) under general anesthesia (2% inhaled anesthetic sevoflurane)
Key secondary outcomes

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	1 months-old <=
Age-upper limit	75 months-old >=
Gender	Male and Female
Key inclusion criteria	Pediatric patients (ASA PS 1-2) undergoing scheduled surgery (inguinal hernia repair and undescended testes surgery)
Key exclusion criteria	Neurologic, neuromuscular, psychiatric, seizure, or blood clotting disorders, or allergy to amide local anesthetics
Target sample size	30

Research contact person
Name of lead principal investigator	Ishitsuka Shunsuke
Organization	University of Tsukuba
Division name	Department of Anesthesiology
Address	Amakubo 2-1-1, Tsukuba City, Ibaraki 305-8575, Japan
TEL	09045060730
Email	dqxmw998@yahoo.co.jp

Public contact
Name of contact person	Ishitsuka Shunsuke
Organization	University of Tsukuba
Division name	Department of Anesthesiology
Address	Amakubo 2-1-1, Tsukuba City, Ibaraki 305-8575, Japan
TEL	09045060730
Homepage URL
Email	dqxmw998@yahoo.co.jp

Sponsor
Institute	University of Tsukuba
Institute
Department

Funding Source
Organization	University of Tsukuba
Organization
Division
Category of Funding Organization	Local Government
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	2017 Year 12 Month 22 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 08 Month 10 Day
Anticipated trial start date	2010 Year 08 Month 10 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	observational study

Management information
Registered date	2017 Year 12 Month 22 Day
Last modified on	2017 Year 12 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033479