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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
ropivacaine concentration determined by up and down sequential method dexamethasone or saline placebo determined by randomisation
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravenous dexamethasone | Experimental | Axillary Brachial Plexus Block with perineural Ropivacaine. Concentration determined by sequential up and down method. Intravenous injection of 8mg/2ml Dexamethasone during the regional anesthesia |
|
| Intravenous saline | Placebo Comparator | Axillary Brachial Plexus Block with perineural Ropivacaine. Concentration determined by sequential up and down method. Intravenous injection of 2ml Saline 0.9% during the regional anesthesia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravenous dexamethasone | Drug | Intravenous injection of 8mg/2ml dexamethasone |
|
| Measure | Description | Time Frame |
|---|---|---|
| Surgical Effectiveness of regional anesthesia at 30min | Ability to perform surgery under regional anaesthesia without supplementary anaesthesia | Time of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| time between regional anesthesia and surgical incision | time between the end of regional anesthesia and the beginning of surgical incision | Time of surgery |
| Effectiveness of regional anaesthesia on Pin-Prick sense |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Francis BERTHIER | Centre Hospitalier Universitaire de Besancon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire de Besançon | Besançon | 25030 | France |
IPD sharing in progress in the institution
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allocation to one of the 2 arm after randomization
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| Intravenous saline | Drug | Intravenous injection of 2ml Saline 0.9% |
|
| Perineural ropivacaine | Drug | Perineural injection of 20ml ropivacaine with adjustment of the concentration determined by sequential up and down method |
|
Defined by a loss of pain sensation at the pinprick test at 30min after the end of regional anaesthesia
| Time of anaesthesia |
| Effectiveness of regional anaesthesia on cold sensation | Defined by a loss of sensation of cold application on skin at 30min after the end of regional anaesthesia | Time of anaesthesia |
| Effectiveness of regional anaesthesia on motor function | Defined by a paresis at 30min after the end of regional anaesthesia (modified bromage score) | Time of anaesthesia |
| recovery of regional anesthesia: pain | time to first pain sensation in the surgical wound after the end of regional anaesthesia | first 48h |
| recovery of regional anesthesia: motor | time to motor recovery of the arm after the end of regional anaesthesia | first 48h |
| recovery of regional anesthesia: sensory | time to sensory recovery of the arm after the end of regional anaesthesia | first 48h |
| complication related to regional anesthesia and/or intravenous dexamethasone | any complication during the first 6 month after the surgery | month 6 |