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Minimal Effective Concentration (EC90) of Ropivacaine (AxiRopiDexa)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03688269
Recruitment Status : Unknown
Verified October 2018 by Centre Hospitalier Universitaire de Besancon.
Recruitment status was:  Recruiting
First Posted : September 28, 2018
Last Update Posted : October 15, 2018
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Anesthesia, Conduction Ropivacaine Dexamethasone Axillary Brachial Plexus Block Drug: Intravenous dexamethasone Drug: Intravenous saline Drug: Perineural ropivacaine Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: allocation to one of the 2 arm after randomization
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Determination of the Minimal Effective Concentration (EC90) of Ropivacaine in Axillary Brachial Plexus Block With Intravenous Dexamethasone or Saline Injection
Actual Study Start Date : October 5, 2018
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : March 31, 2020


Arm Intervention/treatment
Experimental: 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

Drug: Intravenous dexamethasone
Intravenous injection of 8mg/2ml dexamethasone

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

Placebo Comparator: 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

Drug: Intravenous saline
Intravenous injection of 2ml Saline 0.9%

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




Primary Outcome Measures :
  1. Surgical Effectiveness of regional anesthesia at 30min [ Time Frame: Time of surgery ]
    Ability to perform surgery under regional anaesthesia without supplementary anaesthesia


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03688269


Contacts
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Contact: Francis BERTHIER 3 81 21 89 80 ext +33 f1berthier@chu-besancon.fr
Contact: Lucie VETTORETTI 3 81 21 83 78 ext + 33 lvettoretti@chu-besancon.fr

Locations
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France
Centre Hospitalier Universitaire de Besançon Recruiting
Besançon, France, 25030
Contact: Francis BERTHIER         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
Investigators
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Principal Investigator: Francis BERTHIER Centre Hospitalier Universitaire de Besancon
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Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT03688269    
Other Study ID Numbers: P/2018/384
First Posted: September 28, 2018    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: IPD sharing in progress in the institution

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire de Besancon:
regional anesthesia
dexamethasone
ropivacaine
Additional relevant MeSH terms:
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Dexamethasone
Ropivacaine
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents