Clinical trial NCT03688269: Minimal Effective Concentration (EC90) of Ropivacaine
Official title: Determination of the Minimal Effective Concentration (EC90) of Ropivacaine in Axillary Brachial Plexus Block With Intravenous Dexamethasone or Saline Injection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anesthesia, Conduction
Ropivacaine
Dexamethasone
Axillary Brachial Plexus Block
Keywords: regional anesthesia
dexamethasone
ropivacaine
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2018-09-28
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: allocation to one of the 2 arm after randomization
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Surgical Effectiveness of regional anesthesia at 30min
timeFrame: Time of surgery
Secondary outcomes:
measure: time between regional anesthesia and surgical incision
timeFrame: Time of surgery
measure: Effectiveness of regional anaesthesia on Pin-Prick sense
timeFrame: Time of anaesthesia
measure: Effectiveness of regional anaesthesia on cold sensation
timeFrame: Time of anaesthesia
measure: Effectiveness of regional anaesthesia on motor function
timeFrame: Time of anaesthesia
measure: recovery of regional anesthesia: pain
timeFrame: first 48h
measure: recovery of regional anesthesia: motor
timeFrame: first 48h
measure: recovery of regional anesthesia: sensory
timeFrame: first 48h
measure: complication related to regional anesthesia and/or intravenous dexamethasone
timeFrame: month 6
Other outcomes:
Locations:
city: Besançon
country: France
facility: Centre Hospitalier Universitaire de Besançon
Study officials:
affiliation: Centre Hospitalier Universitaire de Besancon
name: Francis BERTHIER
role: PRINCIPAL_INVESTIGATOR
References: