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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029003
Receipt No. R000033185
Official scientific title of the study Percutaneous periarticular analgesic injection at one day after total knee arthroplasty as a component of multimodal pain management: a randomized control trial
Date of disclosure of the study information 2017/09/05
Last modified on 2019/02/09

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Basic information
Official scientific title of the study Percutaneous periarticular analgesic injection at one day after total knee arthroplasty as a component of multimodal pain management: a randomized control trial
Title of the study (Brief title) Percutaneous periarticular analgesic injection at one day after total knee arthroplasty as a component of multimodal pain management: a randomized control trial
Region
Japan

Condition
Condition Osteoarthritis, Avascular necrosis of femoral condyle, Rheumatoid arthritis
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the impact of percutaneous periarticular analgesic injection at one day after total knee arthroplasty on multimodal pain management.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Visual Analogue Scale for postoperative pain at rest measured at 12:00 and 20:00 of one day after surgery, and 6:00, 12:00, and 20:00 of two to five days after surgery.
Key secondary outcomes Complication
Visual Analogue Scale during activity (measured at one to five days after surgery)
Range of knee movement (measured at one to five days after surgery)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Percutaneous periarticular analgesic injection including methylprednisolone 40 mg [1 mL], ropivacaine 150 mg [20 mL], and epinephrine 0.1 mg [0.1 mL] at one day after total knee arthroplasty
Interventions/Control_2 No percutaneous periarticular analgesic injection at one day after total knee arthroplasty
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 scheduled for unilateral total knee arthroplasty
Key exclusion criteria Patients scheduled for simultaneous bilateral total knee arthroplasty.
Patients scheduled for unilateral total knee arthroplasty combined with implant removal.
Patients who had allergy or intolerance to one of the study drugs.
Patients who had poorly controlled diabetic mellitus.
Target sample size 40

Research contact person
Name of lead principal investigator Motohiro Wakui
Organization Nekoyama Miyao Hospital
Division name Orthopaedic Surgery
Address 14-7 Konan, Chuo-ku, Niigata
TEL +81252822323
Email m-wakui@nekoyama.or.jp

Public contact
Name of contact person Sachiyuki Tsukada
Organization Nekoyama Miyao Hospital
Division name Orthopaedic Surgery
Address 14-7 Konan, Chuo-ku, Niigata
TEL +81252822323
Homepage URL
Email s8058@nms.ac.jp

Sponsor
Institute Nekoyama Miyao Hospital
Institute
Department

Funding Source
Organization Self funding
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

Other administrative information
Date of disclosure of the study information
2017 Year 09 Month 05 Day

Progress
Recruitment status Completed
Date of protocol fixation
2017 Year 09 Month 04 Day
Anticipated trial start date
2017 Year 10 Month 01 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 https://bmcmusculoskeletdisord.biomedcentral.com/articles/10.1186/s12891-019-2451-1
Results
Other related information

Management information
Registered date
2017 Year 09 Month 05 Day
Last modified on
2019 Year 02 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033185

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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