UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Pain control after simultaneous bilateral total hip arthroplasty: a randomized controlled trial comparing periarticular injection in one hip and placebo in another hip
Title of the study (Brief title)	Pain control after simultaneous bilateral total hip arthroplasty: a randomized controlled trial comparing periarticular injection in one hip and placebo in another hip
Region	Japan

Condition
Condition	Osteoarthritis of the hip, rheumatoid arthritis, avascular necrosis of the femoral head
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the efficacy of periarticular injection in total hip arthroplasty.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Pain after total hip arthroplasty (evaluated with visual analogue scale)
Key secondary outcomes	Complication

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	One hip is received intraoperative periarticular injections during simultaneous bilateral total hip arthroplasty
Interventions/Control_2	Another hip is received intraoperative normal saline injections during simultaneous bilateral total hip 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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients scheduled for simultaneous bilateral total hip arthroplasty
Key exclusion criteria	Patients with ASA status III-V, renal insufficiency, hepatic insufficiency, prolonged QT interval on electrocardiograms, and allergy or intolerance to one of the study drugs.
Target sample size	17

Research contact person
Name of lead principal investigator	Naoyuki Hirasawa
Organization	Hokusuikai kinen hospital
Division name	Orthopaedic surgery
Address	3-2-1 Higashihara, Mito, Ibaraki, 310-0035 Japan
TEL	029-303-3003
Email	hirari3@orion.ocn.ne.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	2015 Year 02 Month 09 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 02 Month 07 Day
Anticipated trial start date	2015 Year 02 Month 09 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://www.ncbi.nlm.nih.gov/pubmed/29939894
Results
Other related information	https://journals.lww.com/clinorthop/Abstract/publishahead/No_Clinically_Important_Difference_in_Pain_Scores.98464.aspx

Management information
Registered date	2015 Year 02 Month 09 Day
Last modified on	2018 Year 06 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019140