UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013572 |
|---|---|
| Receipt number | R000015836 |
| Scientific Title | Dose-dependent effect of dexamethasone on the duration of interscalene brachial nerve blocks after arthroscopy shoulder surgery |
| Date of disclosure of the study information | 2014/04/01 |
| Last modified on | 2015/11/16 22:33:30 |
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Basic information
Public title
Dose-dependent effect of dexamethasone on the duration of interscalene brachial nerve blocks after arthroscopy shoulder surgery
Acronym
Dose-dependent effect of dexamethasone
Scientific Title
Dose-dependent effect of dexamethasone on the duration of interscalene brachial nerve blocks after arthroscopy shoulder surgery
Scientific Title:Acronym
Dose-dependent effect of dexamethasone
Region
| Japan |
Condition
Condition
arthroscopic shoulder surgery
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the dose-dependent effect of dexamethasone on the duration of interscalene brachial nerve blocks with levobupivacaine
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
duration until first request of analgesics after surgery
Key secondary outcomes
timing and dosage of analgesics afere surgery, pain score on postoerative day 1, patient satisfaction score, quality of sleep, PONV
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Dose comparison
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
control group
interscalene brachial nerve block with revobupibacaine
Interventions/Control_2
dexamethasone 0.5A group
interscalene brachial nerve block with revobupibacaine and 0.5A dexamethasone
Interventions/Control_3
dexamethasone 1A group
interscalene brachial nerve block with revobupibacaine and 1A dexamethasone
Interventions/Control_4
dexamethasone 2A group
interscalene brachial nerve block with revobupibacaine and 2A dexamethasone
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
ASA PS1-2
patient undergoing anthroscopic shoulder surgery
Key exclusion criteria
unsuccessful block
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Michihisa Kato |
Organization
Tokushima Red Cross Hospital
Division name
Anesthesiology
Zip code
Address
Komatsushima Irinokuchi 103
TEL
0885-32-2555
mmkato@tokushima-med.jrc.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kayo Nomura |
Organization
Tokushima Red Cross Hospital
Division name
Anesthesiology
Zip code
Address
Komatsushima Irinokuchi 103
TEL
0885-32-2555
Homepage URL
babibubebob560428@yahoo.co.jp
Sponsor or person
Institute
Tokushima Red Cross 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
徳島赤十字病院（徳島県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2014 | Year | 03 | Month | 12 | Day |
Date of IRB
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
Other
Other related information
Management information
Registered date
| 2014 | Year | 03 | Month | 31 | Day |
Last modified on
| 2015 | Year | 11 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015836
