UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Postoperative analgesia for TKA by femoral and sciatic nerve block with or without buprenorphine
Title of the study (Brief title)	Postoperative analgesia for TKA by femoral and sciatic nerve block with or without buprenorphine
Region	Japan

Condition
Condition	osteoarthritis of the knee
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy of femoral and sciatic nerve block by local anesthetics with or without buprenorphine
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	To compare analgesia and complications using the visual analog scale and post-operative nausea and vomitting score until post-operative day 3
Key secondary outcomes

Base
Study type

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	No treatment
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking	NO
Concealment	Numbered container method

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	without buprenorphine
Interventions/Control_2	local anesthetics with buprenorphine
Interventions/Control_3	buprenorphine im
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	85 years-old >=
Gender	Male and Female
Key inclusion criteria	The patients scheduled TKA
Key exclusion criteria	Past history of allergy for drugs used in the study
Target sample size	60

Research contact person
Name of lead principal investigator	Makiko Komori
Organization	Tokyo Women's Medical University
Division name	Anesthesiology
Address	2-1-10 Nishiogu Arakawaku Tokyo
TEL	03-3810-1111
Email	mkomori@ocn.ne.jp

Public contact
Name of contact person	Mitsuharu Kodaka
Organization	Tokyo Women's Medical University
Division name	Anesthesiology
Address	2-1-10 Nishiogu Arakawaku Tokyo
TEL	03-3810-1111
Homepage URL
Email	kmkodaka@cb3.so-net.ne.jp

Sponsor
Institute	Tokyo Women's Medical University
Institute
Department

Funding Source
Organization	Tokyo Women's Medical University
Organization
Division
Category of Funding Organization	Other
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 03 Month 17 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2013 Year 04 Month 01 Day
Anticipated trial start date	2014 Year 04 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	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 03 Month 17 Day
Last modified on	2017 Year 09 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015071