Intravenous Dexamethasone for Ropivacaine Axillary Block

Postoperative Pain Clinical Trial

— ADEXA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02862327
• Other study ID #: P/2015/275
• Status: Completed
• Phase: Phase 3
• First received: July 22, 2016
• Last updated: January 30, 2018
• Start date: December 1, 2016
• Est. completion date: September 16, 2017

Study information

• Verified date: October 2017
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: September 16, 2017
• Est. primary completion date: March 16, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Forearm Injuries
• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• intravenous dexamethasone
intravenous injection of dexamethasone
• intravenous placebo
intravenous injection of placebo
• 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

Locations

Country	Name	City	State
France	CHRU de Besancon	Besancon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analgesia duration after axillary brachial plexus block		time to first pain at surgical site, an average of 24 hours
Secondary	Motor block duration after axillary brachial plexus block Safety		up to block recovery, an average of 24 hours
Secondary	Sensory block duration after axillary brachial plexus block		up to block recovery, an average of 24 hours
Secondary	incidence of adverse event		6 month