Minimal Effective Concentration (EC90) of Ropivacaine

Centre Hospitalier Universitaire de Besancon146 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

146

Conditions

Anesthesia, Conduction Ropivacaine Dexamethasone Axillary Brachial Plexus Block

Interventions

Intravenous dexamethasoneDRUG

Intravenous injection of 8mg/2ml dexamethasone

Intravenous salineDRUG

Intravenous injection of 2ml Saline 0.9%

Perineural ropivacaineDRUG

Perineural injection of 20ml ropivacaine with adjustment of the concentration determined by sequential up and down method

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Centre Hospitalier Universitaire de Besançon

Besançon, France

Outcomes

Primary Outcomes

Surgical Effectiveness of regional anesthesia at 30min

Ability to perform surgery under regional anaesthesia without supplementary anaesthesia

Time frame: Time of surgery

Secondary Outcomes

time between regional anesthesia and surgical incision

time between the end of regional anesthesia and the beginning of surgical incision

Time frame: Time of surgery

Effectiveness of regional anaesthesia on Pin-Prick sense

Defined by a loss of pain sensation at the pinprick test at 30min after the end of regional anaesthesia

Time frame: 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 frame: 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 frame: Time of anaesthesia

recovery of regional anesthesia: pain

time to first pain sensation in the surgical wound after the end of regional anaesthesia

Time frame: first 48h

recovery of regional anesthesia: motor

time to motor recovery of the arm after the end of regional anaesthesia

Time frame: first 48h

recovery of regional anesthesia: sensory

Data from ClinicalTrials.gov

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