UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025561 |
|---|---|
| Receipt number | 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 15:19:42 |
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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
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
ohgoshi22@gmail.com
Sponsor or person
Institute
International University of Health and Welfare Mita Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029420
