Intravenous Dexamethasone for Ropivacaine Axillary Block

NCT ID: NCT02862327

Last Updated: 2018-01-31

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

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-01

Study Completion Date

2017-09-16

Brief Summary

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Prospective monocentric double-blind controlled randomised trial Aim is to assess prolonged postsurgical analgesia by intravenous dexamethasone versus intravenous placebo, after ultrasound guided axillary brachial plexus block

Detailed Description

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Conditions

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Postoperative Pain Anesthesia Forearm Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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intravenous dexamethasone

intravenous injection of 8mg (2ml) of dexamethasone during regional anesthesia

Group Type ACTIVE_COMPARATOR

intravenous dexamethasone

Intervention Type DRUG

intravenous injection of dexamethasone

perineural ropivacaine

Intervention Type DRUG

brachial plexus block with perineural injection of Ropivacaine in the axillary fossa

ultrasound guidance

Intervention Type OTHER

ultrasound guidance for brachial plexus block in the axillary fossa

intravenous placebo

intravenous injection of 2ml of NaCl 0.9% during regional anesthesia

Group Type PLACEBO_COMPARATOR

intravenous placebo

Intervention Type DRUG

intravenous injection of placebo

perineural ropivacaine

Intervention Type DRUG

brachial plexus block with perineural injection of Ropivacaine in the axillary fossa

ultrasound guidance

Intervention Type OTHER

ultrasound guidance for brachial plexus block in the axillary fossa

Interventions

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intravenous dexamethasone

intravenous injection of dexamethasone

Intervention Type DRUG

intravenous placebo

intravenous injection of placebo

Intervention Type DRUG

perineural ropivacaine

brachial plexus block with perineural injection of Ropivacaine in the axillary fossa

Intervention Type DRUG

ultrasound guidance

ultrasound guidance for brachial plexus block in the axillary fossa

Intervention Type OTHER

Other Intervention Names

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DEXAMETHASONE MYLAN code UCD 9223084 3400892230849

Eligibility Criteria

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Inclusion Criteria

* ASA 1,2 et 3
* surgery under axillary brachial plexus block
* aged \>18 years
* signed information consent

Exclusion Criteria

* impaired coagulation
* contraindication to regional anesthesia or technical impossibility
* opioids or pain killers abuse or addiction
* steroids consumption in the past 6 months
* dementia or under administrative supervision
* delay of surgery to short to allow regional anesthesia
* pregnancy and breastfeeding
* allergy and contraindication to dexamethasone or ropivacaine
* 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

Locations

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CHRU de Besancon

Besançon, , France

Site Status

Countries

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France

References

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Clement JC, Besch G, Puyraveau M, Grelet T, Ferreira D, Vettoretti L, Pili-Floury S, Samain E, Berthier F. Clinical effectiveness of single dose of intravenous dexamethasone on the duration of ropivacaine axillary brachial plexus block: the randomized placebo-controlled ADEXA trial. Reg Anesth Pain Med. 2019 Mar;44(3):e100035. doi: 10.1136/rapm-2018-100035.

Reference Type DERIVED
PMID: 30777900 (View on PubMed)

Other Identifiers

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P/2015/275

Identifier Type: -

Identifier Source: org_study_id

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