UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Peri-Articular Morphine Injection in Total Knee Arthroplasty
Title of the study (Brief title)	Peri-Articular Morphine Injection in Total Knee Arthroplasty
Region	Japan

Condition
Condition	Patients performed total knee arthroplasty
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	to assess whether the addition of morphine to peri-articular knee injections improves postoperative pain, range of motion, and swelling in patients undergoing TKAs
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	postoperative pain, range of motion, swelling
Key secondary outcomes	WOMAC and adverse events

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	patients undergoing TKAs received an intraoperative peri-articular injection with added morphine
Interventions/Control_2	patients undergoing TKAs received an intraoperative peri-articular injection without added morphine.
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	50 years-old <=
Age-upper limit	90 years-old >
Gender	Male and Female
Key inclusion criteria	patients undergoing TKAs with the diagnosis of osteoarthritis and rheumatoid arthritis
Key exclusion criteria	patients undergoing revision TKA, patients with surgical history in knees
Target sample size	100

Research contact person
Name of lead principal investigator	Kentaro Iwakiri
Organization	Shiraniwa Hospital Joint Arthroplasty Center
Division name	Department of Orthopaedic Surgery
Address	6-10-1 Shiraniwadai Ikoma, Nara
TEL	0743-70-0022
Email	kenpiecekenpiece@yahoo.co.jp

Public contact
Name of contact person	Kentaro Iwakiri
Organization	Shiraniwa Hospital Joint Arthroplasty Center
Division name	Department of Orthopaedic Surgery
Address	6-10-1 Shiraniwadai Ikoma, Nara
TEL	0743-70-0022
Homepage URL
Email	kenpiecekenpiece@yahoo.co.jp

Sponsor
Institute	Shiraniwa Hospital Joint Arthroplasty Center
Institute
Department

Funding Source
Organization	none
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	白庭病院

Other administrative information
Date of disclosure of the study information	2015 Year 05 Month 27 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 02 Month 27 Day
Anticipated trial start date	2015 Year 05 Month 27 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
Results
Other related information

Management information
Registered date	2015 Year 05 Month 27 Day
Last modified on	2017 Year 09 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020505