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Completed

NCT Number: NCT03688269

Minimal Effective Concentration (EC90) of Ropivacaine

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

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Key information

Conditions

Anesthesia, Conduction Axillary Brachial Plexus Block Dexamethasone Ropivacaine

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Centre Hospitalier Universitaire de Besançon

Besançon, 25030, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

intravenous dexamethasone

Drug

Intravenous injection of 8mg/2ml dexamethasone

Intravenous saline

Drug

Intravenous injection of 2ml Saline 0.9%

Perineural ropivacaine

Drug

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

Primary outcomes

  1. Surgical Effectiveness of regional anesthesia at 30min

    Time frame: Time of surgery

    Ability to perform surgery under regional anaesthesia without supplementary anaesthesia

Secondary outcomes

  1. time between regional anesthesia and surgical incision

    Time frame: Time of surgery

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

  2. Effectiveness of regional anaesthesia on Pin-Prick sense

    Time frame: Time of anaesthesia

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

  3. Effectiveness of regional anaesthesia on cold sensation

    Time frame: Time of anaesthesia

    Defined by a loss of sensation of cold application on skin at 30min after the end of regional anaesthesia

  4. Effectiveness of regional anaesthesia on motor function

    Time frame: Time of anaesthesia

    Defined by a paresis at 30min after the end of regional anaesthesia (modified bromage score)

  5. recovery of regional anesthesia: pain

    Time frame: first 48h

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

  6. recovery of regional anesthesia: motor

    Time frame: first 48h

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

  7. recovery of regional anesthesia: sensory

    Time frame: first 48h

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

  8. complication related to regional anesthesia and/or intravenous dexamethasone

    Time frame: month 6

    any complication during the first 6 month after the surgery

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Registry information

Official study title

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

Acronym: AxiRopiDexa

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Sep 28, 2018
Registry last updated
Dec 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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