Intravenous Dexamethasone for Ropivacaine Axillary Block (ADEXA)
Primary Purpose
Postoperative Pain, Anesthesia, Forearm Injuries
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
intravenous dexamethasone
intravenous placebo
perineural ropivacaine
ultrasound guidance
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain focused on measuring anaesthetic techniques, regional anesthesia, brachial plexus block, Local Anesthetic, ropivacaine, analgesia, steroid, dexamethasone, placebo, adjuvant, ultrasound guided
Eligibility Criteria
Inclusion Criteria:
- ASA 1,2 et 3
- surgery under axillary brachial plexus block
- aged >18 years
- signed information consent
Exclusion Criteria:
- impaired coagulation
- 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
Sites / Locations
- CHRU de Besancon
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
intravenous dexamethasone
intravenous placebo
Arm Description
intravenous injection of 8mg (2ml) of dexamethasone during regional anesthesia
intravenous injection of 2ml of NaCl 0.9% during regional anesthesia
Outcomes
Primary Outcome Measures
Analgesia duration after axillary brachial plexus block
Secondary Outcome Measures
Motor block duration after axillary brachial plexus block Safety
Sensory block duration after axillary brachial plexus block
incidence of adverse event
Full Information
NCT ID
NCT02862327
First Posted
July 22, 2016
Last Updated
January 30, 2018
Sponsor
Centre Hospitalier Universitaire de Besancon
1. Study Identification
Unique Protocol Identification Number
NCT02862327
Brief Title
Intravenous Dexamethasone for Ropivacaine Axillary Block
Acronym
ADEXA
Official Title
Intravenous Dexamethasone Versus Placebo for Ultrasound Guided Axillary Brachial Plexus Block With Ropivacaine: Randomised, Controlled, Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
December 1, 2016 (Actual)
Primary Completion Date
March 16, 2017 (Actual)
Study Completion Date
September 16, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Besancon
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Prospective monocentric double-blind controlled randomised trial Aim is to assess prolonged postsurgical analgesia by intravenous dexamethasone versus intravenous placebo, after ultrasound guided axillary brachial plexus block
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Anesthesia, Forearm Injuries
Keywords
anaesthetic techniques, regional anesthesia, brachial plexus block, Local Anesthetic, ropivacaine, analgesia, steroid, dexamethasone, placebo, adjuvant, ultrasound guided
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
99 (Actual)
8. Arms, Groups, and Interventions
Arm Title
intravenous dexamethasone
Arm Type
Active Comparator
Arm Description
intravenous injection of 8mg (2ml) of dexamethasone during regional anesthesia
Arm Title
intravenous placebo
Arm Type
Placebo Comparator
Arm Description
intravenous injection of 2ml of NaCl 0.9% during regional anesthesia
Intervention Type
Drug
Intervention Name(s)
intravenous dexamethasone
Other Intervention Name(s)
DEXAMETHASONE MYLAN code UCD 9223084 3400892230849
Intervention Description
intravenous injection of dexamethasone
Intervention Type
Drug
Intervention Name(s)
intravenous placebo
Intervention Description
intravenous injection of placebo
Intervention Type
Drug
Intervention Name(s)
perineural ropivacaine
Intervention Description
brachial plexus block with perineural injection of Ropivacaine in the axillary fossa
Intervention Type
Other
Intervention Name(s)
ultrasound guidance
Intervention Description
ultrasound guidance for brachial plexus block in the axillary fossa
Primary Outcome Measure Information:
Title
Analgesia duration after axillary brachial plexus block
Time Frame
time to first pain at surgical site, an average of 24 hours
Secondary Outcome Measure Information:
Title
Motor block duration after axillary brachial plexus block Safety
Time Frame
up to block recovery, an average of 24 hours
Title
Sensory block duration after axillary brachial plexus block
Time Frame
up to block recovery, an average of 24 hours
Title
incidence of adverse event
Time Frame
6 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ASA 1,2 et 3
surgery under axillary brachial plexus block
aged >18 years
signed information consent
Exclusion Criteria:
impaired coagulation
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
Facility Information:
Facility Name
CHRU de Besancon
City
Besancon
ZIP/Postal Code
25000
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30777900
Citation
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.
Results Reference
derived
Learn more about this trial
Intravenous Dexamethasone for Ropivacaine Axillary Block
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