A Phase 4 interventional study of Placebo and Dexamethasone 1 mg in Postoperative Pain, sponsored by Centre Hospitalier Universitaire Vaudois. Completed at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-01-07.
Sponsored by Centre Hospitalier Universitaire Vaudois · Phase 4, Interventional, and Treatment
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.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's enrollment of 75 is close to the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Centre Hospitalier Universitaire Vaudois is the lead sponsor of 203 studies on the registry; 47 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients will receive ropivacaine 0.5% 20 mls with normal saline 0.9% 2 mls
Drug: Placebo · Drug: Ropivacaine 0.5%
Patients will receive ropivacaine 0.5% 20 mls with dexamethasone 1 mg in 2 mls
Drug: Dexamethasone 1 mg · Drug: Ropivacaine 0.5%
Patients will receive ropivacaine 0.5% 20 mls with dexamethasone 2 mg in 2 mls
Drug: Dexamethasone 2 mg · Drug: Ropivacaine 0.5%
Patients will receive ropivacaine 0.5% 20 mls with dexamethasone 3 mg in 2 mls
Drug: Dexamethasone 3 mg · Drug: Ropivacaine 0.5%
Patients will receive ropivacaine 0.5% 20 mls with dexamethasone 4 mg in 2 mls
Drug: Dexamethasone 4 mg · Drug: Ropivacaine 0.5%
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
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
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Universitaire Vaudois