Dexamethasone in Total Knee and Total Hip Arthroplasty

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Does the Addition of Dexamethasone to a Local Infiltration Analgesia Mixture Improve Functional Outcomes Following Total Joint Arthroplasty?

Conditions
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Total Knee Arthroplasty, Total Hip Arthroplasty, Osteoarthritis

Intervention / Treatment
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* Drug: Dexamethasone
* Other: 0.9% NaCl Placebo
* Drug: LIA Combination Mixture


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexamethasone<br>LIA mixture with the addition of 8mg Dexamethasone. | Drug: Dexamethasone<br>* 8mg (2mL) of Dexamethasone added to standard LIA mixture<br>* Other names: Baycadron;Drug: LIA Combination Mixture<br>* 150mL 2% Ropivacaine, 30mg Ketorolac and 0.6mg of Epinephrine<br>|
| Sham Comparator: Saline<br>LIA mixture with the addition of 2mL of 0.9% NaCl Saline. | Other: 0.9% NaCl Placebo<br>* 2mL of 0.9% NaCl placebo (saline) added to standard LIA mixture<br>* Other names: Saline;Drug: LIA Combination Mixture<br>* 150mL 2% Ropivacaine, 30mg Ketorolac and 0.6mg of Epinephrine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative systemic opioid consumption measured as oral morphine mg equivalents at 24 hours postoperatively |  | 3 days - post operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analgesic outcomes- pain | Pain scores assessed with an 11 point verbal numeric rating scale (NRS) at the following time points: The post-anesthetic care unit (PACU) Postoperative day (POD) 1 at rest between 8-10 AM POD1 during physiotherapy POD 2 at rest between 8 -10 AM POD 2 during physiotherapy g. POD 3 during physiotherapy if still in hospital | 3 days - post operative | 
| Analgesic outcomes- opiate consumption | Cumulative systemic opioid consumption measured as oral morphine mg equivalents on POD 1, POD2, and, if still in hospital, POD 3, as well as the proportion of patients who required rescue intravenous patient controlled analgesia (IV PCA) anytime in the postoperative period | 3 days - post operative | 
| Analgesic outcomes- TUG test | Timed Up and Go Test (TUG) on postoperative days 2 or 3 | 3 days - post operative | 
| Analgesic outcomes- Drug side-effects | Incidence of opioid-related side effects: Nausea and vomiting requiring treatment with anti-emetic Pruritus requiring treatment with antihistamines Sedation requiring treatment with opioid antagonist | 3 days - post operative | 
| Short-term physical and performance-based functional outcome measures- in hospital complications | In-hospital complications- Any outcomes such as MI, surgical site infection, neurological complications, etc. that may have occurred during the hospital stay | 3 days post operative | 
| Short-term physical and performance-based functional outcome measures- length of stay | Hospital length of stay- the total number of days the patient stayed in hospital to recover from elective surgery | 3 days - post operative | 
| Short-term physical and performance-based functional outcome measures- discharge | Discharge destination- determination of location for which the patient was discharged; either to home or to rehabilitation centre | 3 days - post operatively | 
| Medium-term self-reported functional outcome measures- WOMAC | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) measured at baseline and at 3 months post-operatively | 3 months- post operative | 
| Medium-term self-reported functional outcome measures- LFES | Lower extremity functional scale (LEFS) measured at baseline and at 3 months post-operatively | 3 months- post operative |