UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Ultrasound-guided lateral approach for sciatic nerve block: a comparison with the anterior approach
Title of the study (Brief title)	Ultrasound-guided lateral approach for sciatic nerve block
Region	Japan

Condition
Condition	Disease on distal to the knee requiring orthopedic surgery
Classification by specialty	Orthopedics Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the incidence of posterior femoral cutaneous nerve block by different approaches of sciatic nerve block
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Incidence of posterior femoral cutaneous nerve block at 30 min after execution of a sciatic nerve block
Key secondary outcomes	1. Incidence of sensory block by a sciatic nerve block within 30 min after execution of a sciatic nerve block 2. Incidence of motor block by a sciatic nerve block within 30 min after execution of a sciatic nerve block 3. Time required to identify the sciatic nerve under ultrasound 4. Distance from the skin to the sciatic nerve 5. Needle distance under the skin when the tip of the needle reaching the sciatic nerve 6. Time required to perform a sciatic nerve block 7. Incidence of adverse effects caused by a sciatic nerve block

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	To perform a sciatic nerve block using the anterior approach
Interventions/Control_2	To perform a sciatic nerve block using the lateral approach
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	Male and Female
Key inclusion criteria	1. Patients undergoing a unilateral lower extremity surgery on distal to the knee under general anesthesia combined with peripheral nerve blocks 2. American Society of Anesthesiologists PS 1-3 3. Written informed consent is provided
Key exclusion criteria	1. Inability to communicate lucidly 2. Infection at the injection site 3. Prior surgery on the ipsilateral hip or femur 4. BMI > 35 kg/m2 5. BW < 40 kg 6. Allergy to local anesthetics 7. Pre-existing sensory disturbance of the ipsilateral lower extremity 8. Patients who are regarded ineligible by researchers with any other reasons
Target sample size	40

Research contact person
Name of lead principal investigator	Takayuki Yoshida
Organization	Kansai Medical University Hospital
Division name	Department of Anesthesiology
Address	2-3-1, Shin-machi, Hirakata-city, Osaka, Japan
TEL	+81-72-804-0101
Email	ytaka@mac.com

Public contact
Name of contact person	Takayuki Yoshida
Organization	Kansai Medical University Hospital
Division name	Department of Anesthesiology
Address	2-3-1, Shin-machi, Hirakata-city, Osaka, Japan
TEL	+81-72-804-0101
Homepage URL
Email	ytaka@mac.com

Sponsor
Institute	Department of Anesthesiology, Kansai Medical University Hospital
Institute
Department

Funding Source
Organization	Department of Anesthesiology, Kansai Medical University 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	2017 Year 03 Month 31 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 03 Month 08 Day
Anticipated trial start date	2017 Year 04 Month 01 Day
Last follow-up date	2017 Year 11 Month 10 Day
Date of closure to data entry	2017 Year 11 Month 10 Day
Date trial data considered complete	2017 Year 11 Month 10 Day
Date analysis concluded	2017 Year 11 Month 30 Day

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

Management information
Registered date	2017 Year 03 Month 28 Day
Last modified on	2017 Year 11 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029119