Dexamethasone in Total Knee and Total Hip Arthroplasty

• Status: Unknown status
• Trial end date: 2018-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate if the addition of dexamethasone to a local infiltration analgesia mixture will improve functional outcomes following total hip and knee arthroplasty.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Health Network, Toronto
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

Criteria

Inclusion Criteria:

• Undergoing elective, primary, unilateral total hip or knee arthroplasty under spinal anesthesia

• ASA-PS I-III

• 18-85 years of age, inclusive

• 50-100 kg, inclusive

• BMI 18 - 40

Exclusion Criteria:

• Revision hip/knee arthroplasty

• Bilateral hip/knee arthroplasty

• Inability or refusal to provide informed consent

• Any contraindication to spinal anesthesia (e.g., bleeding diathesis, infection, neuropathy)

• Allergy to local anesthesia, ketorolac or dexamethasone

• Allergy to opioids

• Chronic pain state, neuropathic pain

• Opioid dependence

• Diabetic patients will NOT be excluded except those with significant peripheral neuropathy