Dexamethasone in Total Knee and Total Hip Arthroplasty

University Health Network, Toronto

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Total Hip Arthroplasty; Osteoarthritis; Total Knee Arthroplasty

Treatments: Other: 0.9% NaCl Placebo; Drug: Dexamethasone; Drug: LIA Combination Mixture

Study type: Interventional

Funder types: Other

Identifiers

NCT02760043

UHN15-9898-A

Details and patient eligibility

About

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.

Full description

The addition of dexamethasone to an local infiltration analgesia (LIA) mixture for postoperative analgesia following total knee arthroplasty (TKA) has a limited evidence base. Although there is increasing support in the literature for its use in peripheral nerve blockade, there have only been a handful of studies assessing its applicability in periarticular LIA. Moreover, the evidence from peripheral nerve blocks suggests that one of the key benefits of dexamethasone is a prolongation of nerve blockade. Additionally, dexamethasone has been shown to prolong the local analgesic effect of bupivacaine microcapsules.

With respect to total hip arthroplasty (THA), there have only been two small studies that included corticosteroids in the LIA mixture; there was analgesic benefit and better early rehabilitation outcomes when compared to placebo. However, there is limited high-quality evidence for either THA or TKA demonstrating an improvement in functional outcomes when dexamethasone is used in an LIA mixture. 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.

Enrollment: 314 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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314 participants in 2 patient groups

Dexamethasone

Experimental group

Description:

LIA mixture with the addition of 8mg Dexamethasone.

Treatment:

Drug: LIA Combination Mixture

Drug: Dexamethasone

Saline

Sham Comparator group

Description:

LIA mixture with the addition of 2mL of 0.9% NaCl Saline.

Treatment:

Drug: LIA Combination Mixture

Other: 0.9% NaCl Placebo