Minimal Effective Concentration (EC90) of Ropivacaine (AxiRopiDexa)

December 18, 2020 updated by: Centre Hospitalier Universitaire de Besancon

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

146

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Besançon, France, 25030
        • Centre Hospitalier Universitaire de Besançon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical Effectiveness of regional anesthesia at 30min
Time Frame: Time of surgery
Ability to perform surgery under regional anaesthesia without supplementary anaesthesia
Time of surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time of surgery
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
Time of anaesthesia
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
Time of anaesthesia
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)
Time of anaesthesia
recovery of regional anesthesia: pain
Time Frame: first 48h
time to first pain sensation in the surgical wound after the end of regional anaesthesia
first 48h
recovery of regional anesthesia: motor
Time Frame: first 48h
time to motor recovery of the arm after the end of regional anaesthesia
first 48h
recovery of regional anesthesia: sensory
Time Frame: first 48h
time to sensory recovery of the arm after the end of regional anaesthesia
first 48h
complication related to regional anesthesia and/or intravenous dexamethasone
Time Frame: month 6
any complication during the first 6 month after the surgery
month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Besancon

Investigators

  • Principal Investigator: Francis BERTHIER, Centre Hospitalier Universitaire de Besançon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 5, 2018

Primary Completion (ACTUAL)

November 4, 2019

Study Completion (ACTUAL)

May 4, 2020

Study Registration Dates

First Submitted

September 14, 2018

First Submitted That Met QC Criteria

September 25, 2018

First Posted (ACTUAL)

September 28, 2018

Study Record Updates

Last Update Posted (ACTUAL)

December 21, 2020

Last Update Submitted That Met QC Criteria

December 18, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P/2018/384

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

IPD sharing in progress in the institution

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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