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Minimal Effective Concentration (EC90) of Ropivacaine

NCT ID: NCT03688269

Last Updated: 2020-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

146 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-05

Study Completion Date

2020-05-04

Brief Summary

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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

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

Conditions

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Anesthesia, Conduction Ropivacaine Dexamethasone Axillary Brachial Plexus Block

Keywords

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regional anesthesia dexamethasone ropivacaine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

allocation to one of the 2 arm after randomization
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Intravenous dexamethasone

Intervention Type DRUG

Intravenous injection of 8mg/2ml dexamethasone

Perineural ropivacaine

Intervention Type DRUG

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

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

Group Type PLACEBO_COMPARATOR

Intravenous saline

Intervention Type DRUG

Intravenous injection of 2ml Saline 0.9%

Perineural ropivacaine

Intervention Type DRUG

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

Interventions

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Intravenous dexamethasone

Intravenous injection of 8mg/2ml dexamethasone

Intervention Type DRUG

Intravenous saline

Intravenous injection of 2ml Saline 0.9%

Intervention Type DRUG

Perineural ropivacaine

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Francis BERTHIER

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Besancon

Locations

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Centre Hospitalier Universitaire de Besançon

Besançon, , France

Site Status

Countries

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France

Other Identifiers

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P/2018/384

Identifier Type: -

Identifier Source: org_study_id