Minimal Effective Concentration (EC90) of Ropivacaine (AxiRopiDexa)

Centre Hospitalier Universitaire de Besancon

Status and phase: Completed; Phase 3

Conditions: Anesthesia, Conduction; Ropivacaine; Axillary Brachial Plexus Block; Dexamethasone

Treatments: Drug: Intravenous dexamethasone; Drug: Intravenous saline; Drug: Perineural ropivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT03688269

P/2018/384

Details and patient eligibility

About

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

Full description

ropivacaine concentration determined by up and down sequential method dexamethasone or saline placebo determined by randomisation

Enrollment: 146 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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146 participants in 2 patient groups, including a placebo group

Intravenous dexamethasone

Experimental group

Description:

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

Treatment:

Drug: Perineural ropivacaine

Drug: Intravenous dexamethasone

Intravenous saline

Placebo Comparator group

Description:

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

Treatment:

Drug: Intravenous saline

Drug: Perineural ropivacaine