UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The opportune time for periarticular injection during total knee arthroplasty under general anesthesia: a randomized controlled trial
Title of the study (Brief title)	The opportune time for periarticular injection during total knee arthroplasty under general anesthesia: a randomized controlled trial
Region	Japan

Condition
Condition	Osteoarthritis of the knee, rheumatoid arthritis, avascular necrosis
Classification by specialty	Orthopedics Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to compare the efficacy of periarticular injection between the superficial injection after the implantation of prosthesis and the superficial injection just prior to the arthrotomy in total knee arthroplasty under general anesthesia. In the both groups, the deep injection is performed just prior to the implantation of prosthesis.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Pain score (Visual analogue scale) at recovery room
Key secondary outcomes	Pain score (Visual analogue scale) 3 and 6 hours after surgery and 1 day after surgery Blood loss Complications The consumption of remifentanil The use of naloxone

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking	NO
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine Maneuver
Interventions/Control_1	Superficial injection after the implantation of prosthesis
Interventions/Control_2	Superficial injection just prior to the arthrotomy
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	18 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 who had allergy or intolerance to one of the study drugs, regular narcotic use, renal insufficiency and prolonged QT interval on ECG.
Target sample size	40

Research contact person
Name of lead principal investigator	Sachiyuki Tsukada
Organization	Hokusuikai Kinen Hospital
Division name	Orthopaedic surgery
Address	3-2-1 Higashihara, Mito, Ibaraki, 310-0035 Japan
TEL	029-303-3003
Email	s8058@nms.ac.jp

Public contact
Name of contact person	Sachiyuki Tsukada
Organization	Hokusuikai kinen hospital
Division name	Orthopaedic surgery
Address	3-2-1 Higashihara, Mito, Ibaraki, 310-0035 Japan
TEL	029-303-3003
Homepage URL
Email	s8058@nms.ac.jp

Sponsor
Institute	Hokusuikai Kinen Hospital
Institute
Department

Funding Source
Organization	Hokusuikai Kinen Hospital
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	2016 Year 04 Month 14 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 02 Month 17 Day
Anticipated trial start date	2016 Year 09 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://link.springer.com/article/10.1007%2Fs00167-018-5140-y
Results
Other related information

Management information
Registered date	2016 Year 04 Month 14 Day
Last modified on	2018 Year 09 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025272