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Completed

NCT Number: NCT02862327

Intravenous Dexamethasone for Ropivacaine Axillary Block

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

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Key information

Conditions

Postoperative Pain Agnosia Anesthesia Arm Injuries Forearm Injuries Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Postoperative Complications Signs and Symptoms Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHRU de Besancon

Besançon, 25000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

intravenous dexamethasone

Drug

intravenous injection of dexamethasone

Other names: DEXAMETHASONE MYLAN code UCD 9223084 3400892230849

Intravenous placebo

Drug

intravenous injection of placebo

Perineural ropivacaine

Drug

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

Ultrasound guidance

Other

ultrasound guidance for brachial plexus block in the axillary fossa

Primary outcomes

  1. Analgesia duration after axillary brachial plexus block

    Time frame: time to first pain at surgical site, an average of 24 hours

Secondary outcomes

  1. Motor block duration after axillary brachial plexus block Safety

    Time frame: up to block recovery, an average of 24 hours

  2. Sensory block duration after axillary brachial plexus block

    Time frame: up to block recovery, an average of 24 hours

  3. incidence of adverse event

    Time frame: 6 month

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Registry information

Official study title

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

Acronym: ADEXA

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 11, 2016
Registry last updated
Jan 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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