Osteoarthritis, Total Hip Arthroplasty, Total Knee Arthroplasty
Conditions
Brief 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.
Detailed 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.
Interventions
DRUGDexamethasone
8mg (2mL) of Dexamethasone added to standard LIA mixture
OTHER0.9% NaCl Placebo
2mL of 0.9% NaCl placebo (saline) added to standard LIA mixture
DRUGLIA Combination Mixture
150mL 2% Ropivacaine, 30mg Ketorolac and 0.6mg of Epinephrine
Sponsors
University Health Network, Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cumulative systemic opioid consumption measured as oral morphine mg equivalents at 24 hours postoperatively | 3 days - post operative |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Analgesic outcomes- opiate consumption | 3 days - post operative | 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 |
| Analgesic outcomes- TUG test | 3 days - post operative | Timed Up and Go Test (TUG) on postoperative days 2 or 3 |
| Analgesic outcomes- Drug side-effects | 3 days - post operative | Incidence of opioid-related side effects: 1. Nausea and vomiting requiring treatment with anti-emetic 2. Pruritus requiring treatment with antihistamines 3. Sedation requiring treatment with opioid antagonist |
| Short-term physical and performance-based functional outcome measures- in hospital complications | 3 days post operative | In-hospital complications- Any outcomes such as MI, surgical site infection, neurological complications, etc. that may have occurred during the hospital stay |
| Analgesic outcomes- pain | 3 days - post operative | Pain scores assessed with an 11 point verbal numeric rating scale (NRS) at the following time points: 1. The post-anesthetic care unit (PACU) 2. Postoperative day (POD) 1 at rest between 8-10 AM 3. POD1 during physiotherapy 4. POD 2 at rest between 8 -10 AM 5. POD 2 during physiotherapy g. POD 3 during physiotherapy if still in hospital |
| Short-term physical and performance-based functional outcome measures- discharge | 3 days - post operatively | Discharge destination- determination of location for which the patient was discharged; either to home or to rehabilitation centre |
| Medium-term self-reported functional outcome measures- WOMAC | 3 months- post operative | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) measured at baseline and at 3 months post-operatively |
| Medium-term self-reported functional outcome measures- LFES | 3 months- post operative | Lower extremity functional scale (LEFS) measured at baseline and at 3 months post-operatively |
| Short-term physical and performance-based functional outcome measures- length of stay | 3 days - post operative | Hospital length of stay- the total number of days the patient stayed in hospital to recover from elective surgery |
Countries
Canada
Contacts
Primary ContactVincent Chan, MD
Backup ContactKariem El-Boghdadly, MD
Outcome results
None listed