Minimal Effective Concentration (EC90) of Ropivacaine

Phase 3

Completed

• Conditions: Ropivacaine; Axillary Brachial Plexus Block; Dexamethasone; Anesthesia, Conduction
• Interventions: Drug: Intravenous dexamethasone; Drug: Intravenous saline; Drug: Perineural ropivacaine

• Registration Number: NCT03688269
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

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

Study Timeline

• Study First Submitted: 2018-09-14
• Study First Submitted QC: 2018-09-25
• Study First Posted: 2018-09-28
• Study Start: 2018-10-05
• Primary Completion: 2019-11-04
• Study Completion: 2020-05-04
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-18
• Last Update Posted: 2020-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 146

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intravenous dexamethasone	Intravenous dexamethasone	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	Intravenous saline	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
Intravenous dexamethasone	Perineural ropivacaine	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	Perineural ropivacaine	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

Primary Outcome Measures

Name	Time	Method
Surgical Effectiveness of regional anesthesia at 30min	Time of surgery	Ability to perform surgery under regional anaesthesia without supplementary anaesthesia

Secondary Outcome Measures

Name	Time	Method
time between regional anesthesia and surgical incision	Time of surgery	time between the end of regional anesthesia and the beginning of surgical incision
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)
recovery of regional anesthesia: pain	first 48h	time to first pain sensation in the surgical wound 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
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
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

Trial Locations

Locations (1)

Centre Hospitalier Universitaire de Besançon; 🇫🇷 Besançon, France