UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The Significance of Continuous Sciatic Nerve Block to Continuous Femoral Nerve Block for Analgesia After High Tibial Osteotomy A Prospective, Randomized, Double-Blind Study
Title of the study (Brief title)	The Significance of Continuous Sciatic Nerve Block to Continuous Femoral Nerve Block for Analgesia After High Tibial Osteotomy A Prospective, Randomized, Double-Blind Study
Region	Japan

Condition
Condition	Knee Osteoarthritis
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the significance of sciatic nerve block to femoral nerve block after high tibial osteotomy.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	The number of IV PCA boluses
Key secondary outcomes	The number of patients accomplished the trial, postoperative visual analog scale score (VAS score) at rest and at motion, the distribution of pain, the time of initial IV PCA bolus, postoperative nausea and vomiting (PONV), postoperative motor and neurological impairment and total amount of opioid used intraoperatively.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	continuous femoral nerve block
Interventions/Control_2	continuous sciatic nerve 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

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	unilateral HTO ASA-PS 1 or 2
Key exclusion criteria	DM patient with neuropathy neuromuscular disease vascular insufficiency of the lower limb cognitive dysfunction BMI over 35 renal impairment(eGFR under 60) liver dysfunction allergy to the drug used stomach ulcer pregnancy or lactation QTc over 0.44 enable to take the block position not appropriate for the study, dicision made by the doctor
Target sample size	50

Research contact person
Name of lead principal investigator	Hamada Takako
Organization	Yokohama City University Hospital
Division name	Anesthesiology
Address	3-9 Fukuura Kanazawa-ku Yokohama-city Kanagawa Pref.
TEL	045-787-2800
Email	hamadatakako@hotmail.co.jp

Public contact
Name of contact person	Hamada Takako
Organization	Yokohama City University Hospital
Division name	Anesthesiology
Address	3-9 Fukuura Kanazawa-ku Yokohama-city Kanagawa Pref.
TEL	045-787-2800
Homepage URL
Email	hamadatakako@hotmail.co.jp

Sponsor
Institute	Yokohama City University Hospital
Institute
Department

Funding Source
Organization	none
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 11 Month 07 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2015 Year 11 Month 17 Day
Anticipated trial start date	2016 Year 03 Month 07 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 11 Month 07 Day
Last modified on	2016 Year 11 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023431