UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Percutaneous periarticular analgesic injection at one day after simultaneous bilateral 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 simultaneous bilateral 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 simultaneous bilateral 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 80 mg [2 mL], ropivacaine 150 mg [20 mL], and epinephrine 0.2 mg [0.2 mL] at one day after simultaneous bilateral total knee arthroplasty
Interventions/Control_2	No percutaneous periarticular analgesic injection at one day after simultaneous bilateral 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 simultaneous bilateral total knee arthroplasty
Key exclusion criteria	Patients scheduled for unilateral total knee arthroplasty. Patients scheduled for 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	32

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	Takuya Iseki
Organization	Nekoyama Miyao Hospital
Division name	Orthopaedic Surgery
Address	14-7 Konan, Chuo-ku, Niigata
TEL	+81252822323
Homepage URL
Email	takuyaiseki@gmail.com

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 11 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 10 Month 30 Day
Anticipated trial start date	2017 Year 11 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	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 10 Month 30 Day
Last modified on	2018 Year 04 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034000