Minimal Effective Concentration (EC90) of Ropivacaine

Dexamethasone Clinical Trial

— AxiRopiDexa  

Official title:

Determination of the Minimal Effective Concentration (EC90) of Ropivacaine in Axillary Brachial Plexus Block With Intravenous Dexamethasone or Saline Injection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03688269
• Other study ID #: P/2018/384
• Status: Completed
• Phase: Phase 3
• Start date: October 5, 2018
• Est. completion date: May 4, 2020

Study information

• Verified date: December 2020
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: May 4, 2020
• Est. primary completion date: November 4, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia, Conduction
• Axillary Brachial Plexus Block
• Dexamethasone
• Ropivacaine

Intervention

Drug:
• Intravenous dexamethasone
Intravenous injection of 8mg/2ml dexamethasone
• Intravenous saline
Intravenous injection of 2ml Saline 0.9%
• Perineural ropivacaine
Perineural injection of 20ml ropivacaine with adjustment of the concentration determined by sequential up and down method

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire de Besançon	Besançon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical Effectiveness of regional anesthesia at 30min	Ability to perform surgery under regional anaesthesia without supplementary anaesthesia	Time of surgery
Secondary	time between regional anesthesia and surgical incision	time between the end of regional anesthesia and the beginning of surgical incision	Time of surgery
Secondary	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 of anaesthesia
Secondary	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
Secondary	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
Secondary	recovery of regional anesthesia: pain	time to first pain sensation in the surgical wound after the end of regional anaesthesia	first 48h
Secondary	recovery of regional anesthesia: motor	time to motor recovery of the arm after the end of regional anaesthesia	first 48h
Secondary	recovery of regional anesthesia: sensory	time to sensory recovery of the arm after the end of regional anaesthesia	first 48h
Secondary	complication related to regional anesthesia and/or intravenous dexamethasone	any complication during the first 6 month after the surgery	month 6