UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The analgesic efficacy of dexamethasone as a ropivacaine adjuvant in selective tibial nerve block for total knee arthroplasty: a randomized controlled study
Title of the study (Brief title)	The analgesic efficacy of dexamethasone as a ropivacaine adjuvant in selective tibial nerve block for total knee arthroplasty: a randomized controlled study
Region	Japan

Condition
Condition	Case to undergo total knee arthroplasty.
Classification by specialty	Orthopedics Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Assess the analgesic efficacy of adding dexamethasone to the selective tibial nerve block for total knee arthroplasty.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Pain score
Key secondary outcomes	Elapsed time until first additional analgesia after surgery/tibial nerve block

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	0.375% ropivacaine 5 mL + dexamethasone 4 mg(1 ml)
Interventions/Control_2	0.375% ropivacaine 5 mL + serine 1 ml
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	90 years-old >
Gender	Male and Female
Key inclusion criteria	Patients (American Society of Anesthesiologists physical status I-III) scheduled for total knee arthroplasty.
Key exclusion criteria	Patients were excluded if they were younger than 20-yr or older than 90-yr old, had a history of allergy to local anesthetics, had a neurological disorder affecting the corresponding region, using opioids, or were pregnat.
Target sample size	100

Research contact person
Name of lead principal investigator	Yuichi Ohgoshi
Organization	International University of Health and Welfare Mita Hospital
Division name	Department of Anesthesiology
Address	1-4-3 Mita, Minato-ku, Tokyo, 108-8329, Japan
TEL	+81-3-34518121
Email	ohgoshi22@gmail.com

Public contact
Name of contact person	Yuichi Ohgoshi
Organization	International University of Health and Welfare Mita Hospital
Division name	Department of Anesthesiology
Address	1-4-3 Mita, Minato-ku, Tokyo, 108-8329, Japan
TEL	+81-3-34518121
Homepage URL
Email	ohgoshi22@gmail.com

Sponsor
Institute	International University of Health and Welfare Mita Hospital
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

Other administrative information
Date of disclosure of the study information	2017 Year 01 Month 14 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2016 Year 11 Month 09 Day
Anticipated trial start date	2017 Year 01 Month 15 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 01 Month 06 Day
Last modified on	2017 Year 04 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029420