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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Placebo Comparator | Patients will receive ropivacaine 0.5% 20 mls with normal saline 0.9% 2 mls |
|
| Dex 1 | Active Comparator | Patients will receive ropivacaine 0.5% 20 mls with dexamethasone 1 mg in 2 mls |
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| Dex 2 | Active Comparator | Patients will receive ropivacaine 0.5% 20 mls with dexamethasone 2 mg in 2 mls |
|
| Dex 3 | Active Comparator | Patients will receive ropivacaine 0.5% 20 mls with dexamethasone 3 mg in 2 mls |
|
| Dex 4 | Active Comparator | Patients will receive ropivacaine 0.5% 20 mls with dexamethasone 4 mg in 2 mls |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Normal saline 0.9% in 2 mls |
| |
| Dexamethasone 1 mg |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of analgesia | 24hour |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of motor block | 24hour | |
| Onset time of action of sensory block | 1hour | |
| Onset time of action of motor block |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric Albrecht, MD | Centre Hospitalier Universitaire Vaudois | Study Director |
| Matthias Matthias, MD | AZ Groeninge Hospital, Pres. Kennedylaan 4, 8500 Kortrijk, Belgium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AZ Groeninge Hospital | Kortrijk | 8500 | Belgium |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| Drug |
Dexamethasone 1 mg in 2 mls |
|
| Dexamethasone 2 mg | Drug | Dexamethasone 2 mg in 2 mls |
|
| Dexamethasone 3 mg | Drug | Dexamethasone 3 mg in 2 mls |
|
| Dexamethasone 4 mg | Drug | Dexamethasone 4 mg in 2 mls |
|
| Ropivacaine 0.5% | Drug | Ropivacaine 0.5% 20 mls |
|
| 1hour |
| Equivalent morphine consumption in postanesthetic care unit | 4hour |
| Equivalent morphine consumption on postoperative day 1 | 24hour |
| Pain scores at rest in postanesthetic care unit (visual analogue scale, 0-10) | 4hour |
| Pain scores on movement in postanesthetic care unit (visual analogue scale, 0-10) | 4hour |
| Pain scores at rest on postoperative day 1 (visual analogue scale, 0-10) | 24hour |
| Pain scores on movement on postoperative day 1 (visual analogue scale, 0-10) | 24hour |
| Rate of postoperative nausea and vomiting (PONV) | Presence of PONV (YES/NO) | 24hour |
| Rate of pruritus | Presence of pruritus (YES/NO) | 24hour |
| Satisfaction score on postoperative day 1 (visual analogue scale, 0-10) | 24hour |
| Glycemia in postanesthetic care unit (mmol/l) | 4hour |
| Rate of infection | Presence of infection (YES/NO) | 24hour |
| Rate of infection | Presence of infection (YES/NO) | 7 days |
| Rate of paresthesia | Presence of paresthesia (YES/NO) | 7 days |
| Rate of muscle weakness | Presence of muscle weakness (YES/NO) | 7 days |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |