Dexamethasone as an Adjuvant to Ropivacaine for the Interscalene Brachial Plexus Block
- Conditions
- Postoperative Pain
- Interventions
- Registration Number
- NCT02818491
- Lead Sponsor
- Centre Hospitalier Universitaire Vaudois
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 75
- patients scheduled for elective shoulder arthroscopy
- duration of surgery less than 4 hours
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dex 1 Dexamethasone 1 mg Patients will receive ropivacaine 0.5% 20 mls with dexamethasone 1 mg in 2 mls Dex 1 Ropivacaine 0.5% Patients will receive ropivacaine 0.5% 20 mls with dexamethasone 1 mg in 2 mls Dex 3 Ropivacaine 0.5% Patients will receive ropivacaine 0.5% 20 mls with dexamethasone 3 mg in 2 mls Control group Ropivacaine 0.5% Patients will receive ropivacaine 0.5% 20 mls with normal saline 0.9% 2 mls Dex 4 Ropivacaine 0.5% Patients will receive ropivacaine 0.5% 20 mls with dexamethasone 4 mg in 2 mls Dex 2 Dexamethasone 2 mg Patients will receive ropivacaine 0.5% 20 mls with dexamethasone 2 mg in 2 mls Dex 3 Dexamethasone 3 mg Patients will receive ropivacaine 0.5% 20 mls with dexamethasone 3 mg in 2 mls Dex 4 Dexamethasone 4 mg Patients will receive ropivacaine 0.5% 20 mls with dexamethasone 4 mg in 2 mls Control group Placebo Patients will receive ropivacaine 0.5% 20 mls with normal saline 0.9% 2 mls Dex 2 Ropivacaine 0.5% Patients will receive ropivacaine 0.5% 20 mls with dexamethasone 2 mg in 2 mls
- Primary Outcome Measures
Name Time Method Duration of analgesia 24hour
- Secondary Outcome Measures
Name Time Method 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 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 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 Onset time of action of motor block 1hour Equivalent morphine consumption in postanesthetic care unit 4hour Equivalent morphine consumption on postoperative day 1 24hour Duration of motor block 24hour Onset time of action of sensory block 1hour Rate of infection 7 days 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)
Trial Locations
- Locations (1)
AZ Groeninge Hospital
🇧🇪Kortrijk, Belgium