Postoperative Pain
Conditions
Brief 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.
Interventions
DRUGPlacebo
Normal saline 0.9% in 2 mls
DRUGDexamethasone 1 mg
Dexamethasone 1 mg in 2 mls
Dexamethasone 2 mg in 2 mls
Dexamethasone 3 mg in 2 mls
Dexamethasone 4 mg in 2 mls
DRUGRopivacaine 0.5%
Ropivacaine 0.5% 20 mls
Sponsors
Centre Hospitalier Universitaire Vaudois
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients scheduled for elective shoulder arthroscopy * duration of surgery less than 4 hours
Exclusion criteria
* allergy to local anaesthetics * history of neck surgery * history of neck radiotherapy * severe respiratory disease * diabetic patient * chronic pain condition * pregnancy * patient suffering from cancer * patient with addicted disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration of analgesia | 24hour |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Onset time of action of sensory block | 1hour | — |
| Onset time of action of motor block | 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 | — |
| Duration of motor block | 24hour | — |
| Rate of postoperative nausea and vomiting (PONV) | 24hour | Presence of PONV (YES/NO) |
| Rate of pruritus | 24hour | Presence of pruritus (YES/NO) |
| Satisfaction score on postoperative day 1 (visual analogue scale, 0-10) | 24hour | — |
| Glycemia in postanesthetic care unit (mmol/l) | 4hour | — |
| Rate of infection | 24hour | Presence of infection (YES/NO) |
| Rate of paresthesia | 7 days | Presence of paresthesia (YES/NO) |
| Rate of muscle weakness | 7 days | Presence of muscle weakness (YES/NO) |
| Pain scores on movement on postoperative day 1 (visual analogue scale, 0-10) | 24hour | — |
Countries
Belgium
Outcome results
None listed