Intravenous Dexamethasone for Ropivacaine Axillary Block (ADEXA)

Centre Hospitalier Universitaire de Besancon

Status and phase: Completed; Phase 3

Conditions: Forearm Injuries; Postoperative Pain; Anesthesia

Treatments: Drug: intravenous dexamethasone; Drug: intravenous placebo; Other: ultrasound guidance; Drug: perineural ropivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT02862327

P/2015/275

Details and patient eligibility

About

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

Enrollment: 99 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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99 participants in 2 patient groups, including a placebo group

intravenous dexamethasone

Active Comparator group

Description:

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

Treatment:

Other: ultrasound guidance

Drug: perineural ropivacaine

Drug: intravenous dexamethasone

intravenous placebo

Placebo Comparator group

Description:

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

Treatment:

Other: ultrasound guidance

Drug: intravenous placebo

Drug: perineural ropivacaine