UMIN-CTR Clinical Trial

Basic information
Public title	Analgesia for total knee arthroplasty:comparing single shot adductor canal block with dexmedetomidine as an adjuvant and continuous femoral nerve block
Acronym	anealgesia for TKA: single shot adductor canal block with dexmedetomidine vs continuous femoral nerve block.
Scientific Title	Analgesia for total knee arthroplasty:comparing single shot adductor canal block with dexmedetomidine as an adjuvant and continuous femoral nerve block
Scientific Title:Acronym	anealgesia for TKA: single shot adductor canal block with dexmedetomidine vs continuous femoral nerve block.
Region	Japan

Condition
Condition	total knee arthroplasty
Classification by specialty	Orthopedics Anesthesiology Rehabilitation medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare analgesic effect and early knee rehabilitation for total knee replacement between adductor canal block using local anesthetic with dexmedetomidine as an adjuvant and continous femoral nerve block
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	rehabilitation progress(time to achieve knee flexion 120 degree)
Key secondary outcomes	rehabilitation progress (time to achieve knee flexion 90 degree, time to start moving to wheel chair and ambulatory, time to stable ambulatory) Visual analog scale postoperative additional analgesics satisfaction questionnaire complication

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	Maneuver
Interventions/Control_1	single shot adductor canal block with 0.75%ropivacaine 15ml+ dexmedetomidine 50mcg Sciatic nerve block with 0.375% ropivacaine 10ml
Interventions/Control_2	single shot femoral nerve block with 0.75% ropivacaine 15ml Sciatic nerve block with 0.375% ropivacaine 10ml continuous femoral nerve block with 0.2%ropivacaine 5ml/h
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	100 years-old >=
Gender	Male and Female
Key inclusion criteria	patient undergoing unilateral total knee arthroplasty patient with ASA-PS I-III
Key exclusion criteria	patient undergoing Bilateral TKA patient undergoing revision TKA patient allergic to local anesthetics patient we consider ineligible
Target sample size	36

Research contact person
Last name of lead principal investigator	1st name TAKEHIKO Middle name Last name NAGAOKA
Organization	Shin-yurigaoka General Hospital
Division name	department of anesthesiology
Zip code	2150026
Address	255 furusawa-toko, Asao, Kawasaki, Kanagawa
TEL	0443229991
Email	takeitezzz@gmail.com

Public contact
1st name of contact person	1st name TAKEHIKO Middle name Last name NAGAOKA
Organization	Shin-Yurigaoka General Hospital
Division name	department of anesthesiology
Zip code	2150026
Address	255 furusawa-toko, Asao, Kawasaki, Kanagawa
TEL	0443229991
Homepage URL
Email	takeitezzz@gmail.com

Sponsor
Institute	Shin-Yurigaoka general hospital
Institute
Department

Funding Source
Organization	Our institution
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Shin-yurigaoka General Hospital
Address	255 furusawa-toko, Asao, Kawasaki, Kanagawa
Tel	0443229991
Email	tadashi.kanbe@mt.strins.or.jp

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	2019 Year 04 Month 10 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 08 Month 12 Day
Date of IRB	2017 Year 06 Month 15 Day
Anticipated trial start date	2017 Year 08 Month 12 Day
Last follow-up date	2019 Year 08 Month 21 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 04 Month 10 Day
Last modified on	2019 Year 04 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032083