Intravenous Dexamethasone to Increase the Analgesic Duration of Interscalene Block

Maisonneuve-Rosemont Hospital

Status: Completed

Conditions: Pain

Treatments: Drug: Dexamethasone; Drug: Normal Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT02412657

dexaISB

Details and patient eligibility

About

Interscalene brachial plexus block provides excellent but time limited analgesia. Intravenous dexamethasone increases the analgesic duration of a single-shot interscalene block with ropivacaine for shoulder arthroscopic surgery. We want to evaluate the effect of two different doses (dexamethasone 10 mg i.v. vs 4 mg i.v. vs placebo) on the analgesic duration of a single-shot inter scalene block. Our study hypothesis is that dexamethasone 4 mg i.v. is equivalent to dexamethasone10 mg i.v. in prolonging the analgesic duration of a single-shot interscalene block with ropivacaine.

Full description

75 patients will be randomly assigned to three groups:

• D10: dexamethasone 10 mg I.V. diluted in normal saline 20cc, immediately after inter scalene block
• D4: dexamethasone 4 mg I.V. diluted in normal saline 20cc, immediately after inter scalene block
• C: control: Normal saline 20cc I.V., immediately after inter scalene block. These patient will be recruited from 3 hospitals, with two surgeons performing the surgeries.

All patients will have their surgery under regional anesthesia only provided by the inter scalene plexus block, with ropivacaine 0.5% 20cc.

In the postoperative period, patients will be given analgesic medication on an as needed basis. They will be instructed to take the first analgesic medication once postoperative shoulder pain has reached >3/10. They will note the time and day at which this outcome occurs.

Enrollment: 75 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Elective shoulder arthroscopy under ropivacaine single-shot interscalene brachial plexus block anesthesia (rotator cuff repair and shoulder decompression)
• ASA I-III
• Age 18-80 years old

Exclusion criteria

• Any contraindication to interscalene brachial plexus block anesthesia
• Interscalene brachial plexus block failure
• Known local anesthetics allergy
• Dexamethasone allergy or intolerance
• Any contraindication to acetaminophen
• Any contraindication to morphine or hydromorphone
• Brachial plexus neuropathies
• Chronic pain syndrome other than shoulder pain
• Routine use of opioid medication
• Routine use of systemic corticosteroid
• Pregnancy
• Weight below 50 kilograms
• Incapability to understand a numeric verbal pain scale
• Incapability to consent
• Patient refusal

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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75 participants in 3 patient groups, including a placebo group

Dexamethasone 10 mg intravenous

Experimental group

Description:

Dexamethasone 10 mg diluted with Normal Saline 17,5 mL i.v. (20 mL total) injected slowly during 30 seconds immediately after performing interscalene brachial plexus block

Treatment:

Drug: Dexamethasone

Dexamethasone 4 mg intravenous

Experimental group

Description:

Dexamethasone 4 mg diluted with Normal Saline 19 mL i.v. (20 mL total) injected slowly during 30 seconds, immediately after performing interscalene brachial plexus block

Treatment:

Drug: Dexamethasone

Normal Saline 20 mL intravenous

Placebo Comparator group

Description:

Normal saline 20 mL injected slowly during 30 seconds, immediately after performing interscalene brachial plexus block

Treatment:

Drug: Normal Saline