Dexamethasone as an Adjuvant to Ropivacaine for the Interscalene Brachial Plexus Block

Vaud University Hospital Center

Status and phase: Completed; Phase 4

Conditions: Postoperative Pain

Treatments: Drug: Dexamethasone 3 mg; Drug: Ropivacaine 0.5%; Drug: Dexamethasone 4 mg; Drug: Dexamethasone 1 mg; Drug: Placebo; Drug: Dexamethasone 2 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT02818491

CER 217/15

Details and patient eligibility

About

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.

Enrollment: 75 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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75 participants in 5 patient groups, including a placebo group

Control group

Placebo Comparator group

Description:

Patients will receive ropivacaine 0.5% 20 mls with normal saline 0.9% 2 mls

Treatment:

Drug: Placebo

Drug: Ropivacaine 0.5%

Dex 1

Active Comparator group

Description:

Patients will receive ropivacaine 0.5% 20 mls with dexamethasone 1 mg in 2 mls

Treatment:

Drug: Dexamethasone 1 mg

Drug: Ropivacaine 0.5%

Dex 2

Active Comparator group

Description:

Patients will receive ropivacaine 0.5% 20 mls with dexamethasone 2 mg in 2 mls

Treatment:

Drug: Dexamethasone 2 mg

Drug: Ropivacaine 0.5%

Dex 3

Active Comparator group

Description:

Patients will receive ropivacaine 0.5% 20 mls with dexamethasone 3 mg in 2 mls

Treatment:

Drug: Dexamethasone 3 mg

Drug: Ropivacaine 0.5%

Dex 4

Active Comparator group

Description:

Patients will receive ropivacaine 0.5% 20 mls with dexamethasone 4 mg in 2 mls

Treatment:

Drug: Dexamethasone 4 mg

Drug: Ropivacaine 0.5%