UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025598 |
|---|---|
| Receipt number | R000029462 |
| Scientific Title | Ultrasound-guided peripheral nerve block versus periarticular injection for pain management after TKA: randomised controlled trial |
| Date of disclosure of the study information | 2017/01/10 |
| Last modified on | 2018/04/28 15:55:49 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Ultrasound-guided peripheral nerve block versus periarticular injection for pain management after TKA: randomised controlled trial
Acronym
Ultrasound-guided peripheral nerve block versus periarticular injection: randomised controlled trial
Scientific Title
Ultrasound-guided peripheral nerve block versus periarticular injection for pain management after TKA: randomised controlled trial
Scientific Title:Acronym
Ultrasound-guided peripheral nerve block versus periarticular injection: randomised controlled trial
Region
| Japan |
Condition
Condition
Osteoarthritis of knee joint
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare ltrasound-guided peripheral nerve blocks versus periarticular injections for pain management after TKA
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pain scale evaluated with 100-mm visual analogue scale (postop.0,2,4,6,8,10,12,18,24,36,48,72h)
Key secondary outcomes
Time of anaesthesia
Narcotic use
Quadriceps function
Range of motion of knee joint
Complication
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are 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
Ultrasound-guided peripheral nerve block
Interventions/Control_2
periarticular injection
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients having knee osteoarthritis scheduled primary TKA
Key exclusion criteria
Patients scheduled simultaneous bilateral TKA
Patients with the drug allergy
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomohiro Ojima |
Organization
Fukui General Hospital
Division name
Orthopaedic surgery
Zip code
Address
58-16-1 Egami, Fukui, 910-8561, JAPAN
TEL
0776-59-1300
ojima@ka2.so-net.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomohiro Ojima |
Organization
Fukui General Hospital
Division name
Orthopaedic surgery
Zip code
Address
58-16-1 Egami, Fukui, 910-8561, JAPAN
TEL
0776-59-1300
Homepage URL
ojima@ka2.so-net.ne.jp
Sponsor or person
Institute
Fukui General Hospital
Institute
Department
Personal name
Funding Source
Organization
Fukui General Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2017 | Year | 01 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2017 | Year | 01 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 01 | Month | 05 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 01 | Month | 10 | Day |
Last modified on
| 2018 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029462
