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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
75
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
AZ Groeninge Hospital
Kortrijk, Belgium
Duration of analgesia
Time frame: 24hour
Duration of motor block
Time frame: 24hour
Onset time of action of sensory block
Time frame: 1hour
Onset time of action of motor block
Time frame: 1hour
Equivalent morphine consumption in postanesthetic care unit
Time frame: 4hour
Equivalent morphine consumption on postoperative day 1
Time frame: 24hour
Pain scores at rest in postanesthetic care unit (visual analogue scale, 0-10)
Time frame: 4hour
Pain scores on movement in postanesthetic care unit (visual analogue scale, 0-10)
Time frame: 4hour
Pain scores at rest on postoperative day 1 (visual analogue scale, 0-10)
Time frame: 24hour
Pain scores on movement on postoperative day 1 (visual analogue scale, 0-10)
Time frame: 24hour
Rate of postoperative nausea and vomiting (PONV)
Presence of PONV (YES/NO)
Time frame: 24hour
Rate of pruritus
Presence of pruritus (YES/NO)
Time frame: 24hour
Satisfaction score on postoperative day 1 (visual analogue scale, 0-10)
Time frame: 24hour
Glycemia in postanesthetic care unit (mmol/l)
Time frame: 4hour
Rate of infection
Presence of infection (YES/NO)
Time frame: 24hour
Rate of infection
Presence of infection (YES/NO)
Time frame: 7 days
Rate of paresthesia
Presence of paresthesia (YES/NO)
Time frame: 7 days
Rate of muscle weakness
Presence of muscle weakness (YES/NO)
Time frame: 7 days
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