Intravenous Dexamethasone for Ropivacaine Axillary Block

Phase 3

Completed

• Conditions: Postoperative Pain; Anesthesia; Forearm Injuries
• Interventions: Drug: intravenous placebo; Drug: intravenous dexamethasone; Drug: perineural ropivacaine; Other: ultrasound guidance

• Registration Number: NCT02862327
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2016-07-22
• Study First Submitted QC: 2016-08-08
• Study First Posted: 2016-08-11
• Study Start: 2016-12-01
• Primary Completion: 2017-03-16
• Study Completion: 2017-09-16
• Status Verified: 2017-10
• Last Update Submitted: 2018-01-30
• Last Update Posted: 2018-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intravenous dexamethasone	perineural ropivacaine	intravenous injection of 8mg (2ml) of dexamethasone during regional anesthesia
intravenous placebo	ultrasound guidance	intravenous injection of 2ml of NaCl 0.9% during regional anesthesia
intravenous dexamethasone	ultrasound guidance	intravenous injection of 8mg (2ml) of dexamethasone during regional anesthesia
intravenous placebo	intravenous placebo	intravenous injection of 2ml of NaCl 0.9% during regional anesthesia
intravenous placebo	perineural ropivacaine	intravenous injection of 2ml of NaCl 0.9% during regional anesthesia
intravenous dexamethasone	intravenous dexamethasone	intravenous injection of 8mg (2ml) of dexamethasone during regional anesthesia

Primary Outcome Measures

Name	Time	Method
Analgesia duration after axillary brachial plexus block	time to first pain at surgical site, an average of 24 hours

Secondary Outcome Measures

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

Trial Locations

Locations (1)

CHRU de Besancon; 🇫🇷 Besancon, France