Intravenous Dexamethasone for Ropivacaine Axillary Block
NCT ID: NCT02862327
Last Updated: 2018-01-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
99 participants
INTERVENTIONAL
2016-12-01
2017-09-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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intravenous dexamethasone
intravenous injection of 8mg (2ml) of dexamethasone during regional anesthesia
intravenous dexamethasone
intravenous injection of dexamethasone
perineural ropivacaine
brachial plexus block with perineural injection of Ropivacaine in the axillary fossa
ultrasound guidance
ultrasound guidance for brachial plexus block in the axillary fossa
intravenous placebo
intravenous injection of 2ml of NaCl 0.9% during regional anesthesia
intravenous placebo
intravenous injection of placebo
perineural ropivacaine
brachial plexus block with perineural injection of Ropivacaine in the axillary fossa
ultrasound guidance
ultrasound guidance for brachial plexus block in the axillary fossa
Interventions
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intravenous dexamethasone
intravenous injection of dexamethasone
intravenous placebo
intravenous injection of placebo
perineural ropivacaine
brachial plexus block with perineural injection of Ropivacaine in the axillary fossa
ultrasound guidance
ultrasound guidance for brachial plexus block in the axillary fossa
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* surgery under axillary brachial plexus block
* aged \>18 years
* signed information consent
Exclusion Criteria
* contraindication to regional anesthesia or technical impossibility
* opioids or pain killers abuse or addiction
* steroids consumption in the past 6 months
* dementia or under administrative supervision
* delay of surgery to short to allow regional anesthesia
* pregnancy and breastfeeding
* allergy and contraindication to dexamethasone or ropivacaine
* anticipated bad observation of treatment
* patient enrolled in another trial
18 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire de Besancon
OTHER
Responsible Party
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Locations
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CHRU de Besancon
Besançon, , France
Countries
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References
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Clement JC, Besch G, Puyraveau M, Grelet T, Ferreira D, Vettoretti L, Pili-Floury S, Samain E, Berthier F. Clinical effectiveness of single dose of intravenous dexamethasone on the duration of ropivacaine axillary brachial plexus block: the randomized placebo-controlled ADEXA trial. Reg Anesth Pain Med. 2019 Mar;44(3):e100035. doi: 10.1136/rapm-2018-100035.
Other Identifiers
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P/2015/275
Identifier Type: -
Identifier Source: org_study_id
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