UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A randomized controlled trial comparing continuous femoral nerve block and local infiltration analgesiafor total knee arthroplasty
Title of the study (Brief title)	A randomized controlled trial comparing continuous femoral nerve block and local infiltration analgesiafor total knee arthroplasty
Region	Japan

Condition
Condition	Osteoarthritis of knee
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the continuous femoral nerve block and local infiltration analgesia for pain after total knee arthroplasty.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Visual analog scale score at rest at 1 day after surgery.
Key secondary outcomes	The postoperative visual analog scale score at rest other than at the 1 day. Total amount of morphine consumption. Post operative labo date. Post operative complication.

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 -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine Maneuver
Interventions/Control_1	A continuous femoral nerve block for pain after total knee arthroplasty (total of 20 ml of 2.0 mg / ml of ropivacaine was injected around the femoral nerve as an initial block. Postoperatively, 1.5 mg / mL of ropivacaine was continuously infused at the rate of 5 mL per hour for 48 hours through the catheter).
Interventions/Control_2	A local infiltration analgesia for pain after total knee arthroplasty (7.5 mg / ml of ropivacaine [40 mL], 100mg of ketoprofen [5 mL ], 1 mg / ml of epinephrine [0.5 mL] and 40 ml of normal saline).
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	60 years-old <=
Age-upper limit	85 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients scheduled for primary unilateral total knee arthroplasty.
Key exclusion criteria	History of allergy or intolerance to one of the study drugs, serious internal co-morbidities, chronic inflammatory joint disease (i.e. rheumatoid arthritis), or bleeding disorder.
Target sample size	40

Research contact person
Name of lead principal investigator	Shinichi Yoshiya
Organization	Hyogo College of Medicine
Division name	Orthopaedic surgery
Address	663-8501 1-1 Mukogawa-cho, Nishinomiya City, Hyogo, Japan
TEL	0798-45-6111
Email	yoshiya@hyo-med.ac.jp

Public contact
Name of contact person	Kenji Kurosaka
Organization	Hyogo College of Medicine
Division name	Orthopaedic surgery
Address	663-8501 1-1 Mukogawa-cho, Nishinomiya City, Hyogo, Japan
TEL	0798-45-6111
Homepage URL
Email	yoshiya@hyo-med.ac.jp

Sponsor
Institute	Hyogo College of Medicine
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	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	兵庫医科大学病院

Other administrative information
Date of disclosure of the study information	2015 Year 08 Month 29 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 08 Month 05 Day
Anticipated trial start date	2010 Year 10 Month 16 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	Published
URL releasing results	http://dx.doi.org/10.1016/j.arth.2015.10.030
Results
Other related information

Management information
Registered date	2015 Year 08 Month 29 Day
Last modified on	2016 Year 04 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-bin/icdr_e/ctr_view.cgi?recptno=R000021804