UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036466
Receipt number R000032083
Scientific Title Analgesia for total knee arthroplasty:comparing single shot adductor canal block with dexmedetomidine as an adjuvant and continuous femoral nerve block
Date of disclosure of the study information 2019/04/10
Last modified on 2019/04/10 17:17:33

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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

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

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 or person

Institute

Shin-Yurigaoka general hospital

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032083


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name