UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of catheter position of continuous nerve block on the rehabilitation of total knee arthroplasty: femoral nerve block vs adductor canal block.
Title of the study (Brief title)	Post TKA rehabilitation: FNB vs ACB
Region	Japan

Condition
Condition	knee osteoarthritis
Classification by specialty	Orthopedics Anesthesiology Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Continuous femoral nerve block (FNB) is popular analgesia for total knee arthroplasty (TKA), however it provides motor weakness of quadriceps muscle of thigh. One of principle problem on acute rehabilitation state is swelling and persisted motor weakness of thigh. Recently, continuous adductor canal block (ACB) is noted much less motor weakness of thigh than femoral nerve block. The aim of this study is to compare the thigh swelling and recovery of motor function of thigh on acute rehabilitation of TKA between FNB and ACB.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	maximum voluntary isometric constriction of quadriceps of thigh
Key secondary outcomes	girth of thigh post operative pain range of motion of knee complication

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	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment Maneuver
Interventions/Control_1	continuous femoral nerve block for 72 hours postoperatively
Interventions/Control_2	continuous adductor canal block for 72 hours postoperatively
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	85 years-old >
Gender	Male and Female
Key inclusion criteria	Patients planning total knee arthroplasty
Key exclusion criteria	Patients with peripheral neuropathy, palsy, obese (BMI>35), anemia, anticoagulant therapy, renal failure, and heart failure
Target sample size	60

Research contact person
Name of lead principal investigator	Tatsuo Nakamoto
Organization	Osaka Rosai Hospital
Division name	Department of anesthesia and pain medicine
Address	1179-3 Nagasone-cho, Kita-ku, Sakai, Osaka, JAPAN
TEL	072-252-3561
Email	tnakamoto@msic.med.osaka-cu.ac.jp

Public contact
Name of contact person	Tatsuo Nakamoto
Organization	Osaka Rosai Hospital
Division name	Department of anesthesia and pain medicine
Address	1179-3 Nagasone-cho, Kita-ku, Sakai, Osaka, JAPAN
TEL	072-252-3561
Homepage URL
Email	tnakamoto@msic.med.osaka-cu.ac.jp

Sponsor
Institute	Department of anesthesia and pain medicine, Osaka Rosai Hospital
Institute
Department

Funding Source
Organization	self funding
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	大阪労災病院（大阪府）

Other administrative information
Date of disclosure of the study information	2015 Year 01 Month 01 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2014 Year 12 Month 19 Day
Anticipated trial start date	2015 Year 01 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	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 12 Month 22 Day
Last modified on	2018 Year 06 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018626