Intravenous Dexamethasone for Ropivacaine Axillary Block (ADEXA)

January 30, 2018 updated by: Centre Hospitalier Universitaire de Besancon

Intravenous Dexamethasone Versus Placebo for Ultrasound Guided Axillary Brachial Plexus Block With Ropivacaine: Randomised, Controlled, Clinical Trial

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

99

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
      • Besancon, France, 25000
        • CHRU 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:

  • 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

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 Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: intravenous dexamethasone
intravenous injection of 8mg (2ml) of dexamethasone during regional anesthesia
Drug: intravenous dexamethasone
intravenous injection of dexamethasone
Other Names:
  • DEXAMETHASONE MYLAN code UCD 9223084 3400892230849
Drug: perineural ropivacaine
brachial plexus block with perineural injection of Ropivacaine in the axillary fossa
Other: ultrasound guidance
ultrasound guidance for brachial plexus block in the axillary fossa
Placebo Comparator: intravenous placebo
intravenous injection of 2ml of NaCl 0.9% during regional anesthesia
Drug: perineural ropivacaine
brachial plexus block with perineural injection of Ropivacaine in the axillary fossa
Other: ultrasound guidance
ultrasound guidance for brachial plexus block in the axillary fossa
Drug: intravenous placebo
intravenous injection of placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Analgesia duration after axillary brachial plexus block
Time Frame: time to first pain at surgical site, an average of 24 hours
time to first pain at surgical site, an average of 24 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Motor block duration after axillary brachial plexus block Safety
Time Frame: up to block recovery, an average of 24 hours
up to block recovery, an average of 24 hours
Sensory block duration after axillary brachial plexus block
Time Frame: up to block recovery, an average of 24 hours
up to block recovery, an average of 24 hours
incidence of adverse event
Time Frame: 6 month
6 month

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire de Besancon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

December 1, 2016

Primary Completion (Actual)

March 16, 2017

Study Completion (Actual)

September 16, 2017

Study Registration Dates

First Submitted

July 22, 2016

First Submitted That Met QC Criteria

August 8, 2016

First Posted (Estimate)

August 11, 2016

Study Record Updates

Last Update Posted (Actual)

January 31, 2018

Last Update Submitted That Met QC Criteria

January 30, 2018

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P/2015/275

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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.

Clinical Trials on Postoperative Pain

Clinical Trials on intravenous dexamethasone

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cote d'Ivoire

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe