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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Enrollment
314
8mg (2mL) of Dexamethasone added to standard LIA mixture
2mL of 0.9% NaCl placebo (saline) added to standard LIA mixture
150mL 2% Ropivacaine, 30mg Ketorolac and 0.6mg of Epinephrine
Toronto Western Hopspital
Toronto, Ontario, Canada
RECRUITINGCumulative systemic opioid consumption measured as oral morphine mg equivalents at 24 hours postoperatively
Time frame: 3 days - post operative
Analgesic outcomes- pain
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
Time frame: 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
Time frame: 3 days - post operative
Analgesic outcomes- TUG test
Timed Up and Go Test (TUG) on postoperative days 2 or 3
Time frame: 3 days - post operative
Analgesic outcomes- Drug side-effects
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
Time frame: 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
Time frame: 3 days post operative
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 3 months- post operative