Intravenous Dexamethasone for Ropivacaine Axillary Block

Study Overview
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Brief Summary
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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

Official Title
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Intravenous Dexamethasone Versus Placebo for Ultrasound Guided Axillary Brachial Plexus Block With Ropivacaine: Randomised, Controlled, Clinical Trial

Conditions
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Postoperative Pain, Anesthesia, Forearm Injuries

Intervention / Treatment
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* Drug: intravenous dexamethasone
* Drug: intravenous placebo
* Drug: perineural ropivacaine
* Other: ultrasound guidance


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: intravenous dexamethasone<br>intravenous injection of 8mg (2ml) of dexamethasone during regional anesthesia | Drug: intravenous dexamethasone<br>* intravenous injection of dexamethasone<br>* Other names: DEXAMETHASONE MYLAN code UCD 9223084 3400892230849;Drug: perineural ropivacaine<br>* brachial plexus block with perineural injection of Ropivacaine in the axillary fossa<br>Other: ultrasound guidance<br>* ultrasound guidance for brachial plexus block in the axillary fossa<br>|
| Placebo Comparator: intravenous placebo<br>intravenous injection of 2ml of NaCl 0.9% during regional anesthesia | Drug: intravenous placebo<br>* intravenous injection of placebo<br>Drug: perineural ropivacaine<br>* brachial plexus block with perineural injection of Ropivacaine in the axillary fossa<br>Other: ultrasound guidance<br>* ultrasound guidance for brachial plexus block in the axillary fossa<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analgesia duration after axillary brachial plexus block |  | time to first pain at surgical site, an average of 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motor block duration after axillary brachial plexus block Safety |  | up to block recovery, an average of 24 hours | 
| Sensory block duration after axillary brachial plexus block |  | up to block recovery, an average of 24 hours | 
| incidence of adverse event |  | 6 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anaesthetic techniques, regional anesthesia, brachial plexus block, Local Anesthetic, ropivacaine, analgesia, steroid, dexamethasone, placebo, adjuvant, ultrasound guided