NCT02818491

Dexamethasone as an Adjuvant to Ropivacaine for the Interscalene Brachial Plexus Block

Dexamethasone as an Adjuvant to Ropivacaine for the Interscalene Brachial Plexus Block: a Dose-finding Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Centre Hospitalier Universitaire Vaudois · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Shoulder surgery is associated with moderate to severe postoperative pain. Interscalene brachial plexus block is considered by many as the gold standard for treating postoperative pain and consists of injecting local anaesthetics close to the nerves of the brachial plexus in the neck. Duration of analgesia is between eight to twelve hours depending on the type of administered drugs. Dexamethasone 4 mg is a steroid routinely injected intravenously in anaesthesia for the prophylaxis of postoperative nausea and vomiting. Recently, different trials have demonstrated that combining 4 to 8 mg of dexamethasone with local anaesthetics for a perineural injection may prolong the duration of analgesia up to 24 hours. In a meta-analysis including 29 trials and 1695 patients, investigators have recently demonstrated through a meta-regression that a dose of 4 mg is sufficient and represents a ceiling dose, without neurological complications. The objective of this multicenter randomised controlled double-blinded trial is to determine the optimal dose of perineural dexamethasone. For that purpose, investigators will include a total of 150 patients divided in 5 groups: local anaesthetics with placebo, or with dexamethasone 1, 2, 3 and 4 mg.

Conditions

• Postoperative Pain

Interventions

Type	Name	Description
DRUG	Placebo	Normal saline 0.9% in 2 mls
DRUG	Dexamethasone 1 mg	Dexamethasone 1 mg in 2 mls
DRUG	Dexamethasone 2 mg	Dexamethasone 2 mg in 2 mls
DRUG	Dexamethasone 3 mg	Dexamethasone 3 mg in 2 mls
DRUG	Dexamethasone 4 mg	Dexamethasone 4 mg in 2 mls
DRUG	Ropivacaine 0.5%	Ropivacaine 0.5% 20 mls

Timeline

• Start date: 2017-11-01
• Primary completion: 2018-11-01
• Completion: 2018-11-01
• First posted: 2016-06-29
• Last updated: 2020-01-07

Locations

1 site across 1 country: Belgium