AZ Groeninge Hospital
Kortrijk, 8500, Belgium
NCT Number: NCT02818491
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Kortrijk, 8500, Belgium
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Normal saline 0.9% in 2 mls
Dexamethasone 1 mg in 2 mls
Dexamethasone 2 mg in 2 mls
Dexamethasone 3 mg in 2 mls
Dexamethasone 4 mg in 2 mls
Ropivacaine 0.5% 20 mls
Time frame: 24hour
Time frame: 24hour
Time frame: 1hour
Time frame: 1hour
Time frame: 4hour
Time frame: 24hour
Time frame: 4hour
Time frame: 4hour
Time frame: 24hour
Time frame: 24hour
Time frame: 24hour
Presence of PONV (YES/NO)
Time frame: 24hour
Presence of pruritus (YES/NO)
Time frame: 24hour
Time frame: 4hour
Time frame: 24hour
Presence of infection (YES/NO)
Time frame: 7 days
Presence of infection (YES/NO)
Time frame: 7 days
Presence of paresthesia (YES/NO)
Time frame: 7 days
Presence of muscle weakness (YES/NO)
Centre Hospitalier Universitaire Vaudois
Other
Dexamethasone as an Adjuvant to Ropivacaine for the Interscalene Brachial Plexus Block: a Dose-finding Study
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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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