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
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
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
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
