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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000025561
Receipt No. R000029420
Scientific Title The analgesic efficacy of dexamethasone as a ropivacaine adjuvant in selective tibial nerve block for total knee arthroplasty: a randomized controlled study
Date of disclosure of the study information 2017/01/14
Last modified on 2017/04/28

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Basic information
Public title The analgesic efficacy of dexamethasone as a ropivacaine adjuvant in selective tibial nerve block for total knee arthroplasty: a randomized controlled study
Acronym The analgesic efficacy of dexamethasone as a ropivacaine adjuvant in selective tibial nerve block for total knee arthroplasty: a randomized controlled study
Scientific Title The analgesic efficacy of dexamethasone as a ropivacaine adjuvant in selective tibial nerve block for total knee arthroplasty: a randomized controlled study
Scientific Title:Acronym 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
1st name
Middle name
Last name Yuichi Ohgoshi
Organization International University of Health and Welfare Mita Hospital
Division name Department of Anesthesiology
Zip code
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
1st name
Middle name
Last name Yuichi Ohgoshi
Organization International University of Health and Welfare Mita Hospital
Division name Department of Anesthesiology
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Terminated
Date of protocol fixation
2016 Year 11 Month 09 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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