Anesthesia, Conduction, Ropivacaine, Dexamethasone, Axillary Brachial Plexus Block
Conditions
Keywords
regional anesthesia, dexamethasone, ropivacaine
Brief summary
Prospective up and down sequential evaluation of the minimal effective concentration of perineural ropivacaine for 90% success in axillary brachial plexus block with the injection of intravenous dexamethasone or saline placebo during regional anesthesia performance
Detailed description
ropivacaine concentration determined by up and down sequential method dexamethasone or saline placebo determined by randomisation
Interventions
Intravenous injection of 8mg/2ml dexamethasone
Intravenous injection of 2ml Saline 0.9%
Perineural injection of 20ml ropivacaine with adjustment of the concentration determined by sequential up and down method
Sponsors
Centre Hospitalier Universitaire de Besancon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
allocation to one of the 2 arm after randomization
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years old or older * ASA Score 1,2 et 3 (American Society of Anesthesiologists Score) * surgery under axillary brachial plexus block * signed information consent
Exclusion criteria
* pregnancy and breastfeeding * contraindication to regional anesthesia or technical impossibility * impaired coagulation * delay of surgery to short to allow regional anesthesia * dementia or under administrative supervision * allergy and contraindication to dexamethasone or ropivacaine * total dose of ropivacaine higher than 3 mg / kg (recommended dose for upper limb regional anesthesia) * opioids or pain killers abuse or addiction * steroids consumption in the past 6 months * surgery estimated to be greater than 4 hours * anticipated bad observation of treatment * patient enrolled in another trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surgical Effectiveness of regional anesthesia at 30min | Time of surgery | Ability to perform surgery under regional anaesthesia without supplementary anaesthesia |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness of regional anaesthesia on Pin-Prick sense | Time of anaesthesia | Defined by a loss of pain sensation at the pinprick test at 30min after the end of regional anaesthesia |
| Effectiveness of regional anaesthesia on cold sensation | Time of anaesthesia | Defined by a loss of sensation of cold application on skin at 30min after the end of regional anaesthesia |
| Effectiveness of regional anaesthesia on motor function | Time of anaesthesia | Defined by a paresis at 30min after the end of regional anaesthesia (modified bromage score) |
| time between regional anesthesia and surgical incision | Time of surgery | time between the end of regional anesthesia and the beginning of surgical incision |
| recovery of regional anesthesia: motor | first 48h | time to motor recovery of the arm after the end of regional anaesthesia |
| recovery of regional anesthesia: sensory | first 48h | time to sensory recovery of the arm after the end of regional anaesthesia |
| complication related to regional anesthesia and/or intravenous dexamethasone | month 6 | any complication during the first 6 month after the surgery |
| recovery of regional anesthesia: pain | first 48h | time to first pain sensation in the surgical wound after the end of regional anaesthesia |
Countries
France
Outcome results
None listed