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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexamethasone | Experimental | LIA mixture with the addition of 8mg Dexamethasone. |
|
| Saline | Sham Comparator | LIA mixture with the addition of 2mL of 0.9% NaCl Saline. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone | Drug | 8mg (2mL) of Dexamethasone added to standard LIA mixture |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative systemic opioid consumption measured as oral morphine mg equivalents at 24 hours postoperatively | 3 days - post operative |
| Measure | Description | Time Frame |
|---|---|---|
| Analgesic outcomes- pain | Pain scores assessed with an 11 point verbal numeric rating scale (NRS) at the following time points:
g. POD 3 during physiotherapy if still in hospital | 3 days - post operative |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vincent Chan, MD | Contact | 4166035118 | vincent.chan@uhn.ca | |
| Kariem El-Boghdadly, MD | Contact | 4166035800 | elboghdadly@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Toronto Western Hopspital | Recruiting | Toronto | Ontario | M5T2S8 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33199379 | Derived | El-Boghdadly K, Short AJ, Gandhi R, Chan V. Addition of dexamethasone to local infiltration analgesia in elective total knee arthroplasty: double-blind, randomized control trial. Reg Anesth Pain Med. 2021 Feb;46(2):130-136. doi: 10.1136/rapm-2020-102079. Epub 2020 Nov 16. | |
| 31563881 | Derived | El-Boghdadly K, Short AJ, Gandhi R, Chan VWS. Addition of dexamethasone to local infiltration analgesia in elective total hip arthroplasty: a double-blind, randomized control trial. Reg Anesth Pain Med. 2019 Sep 27:rapm-2019-100873. doi: 10.1136/rapm-2019-100873. Online ahead of print. |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D002123 | Calcium Dobesilate |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| 0.9% NaCl Placebo | Other | 2mL of 0.9% NaCl placebo (saline) added to standard LIA mixture |
|
|
| LIA Combination Mixture | Drug | 150mL 2% Ropivacaine, 30mg Ketorolac and 0.6mg of Epinephrine |
|
| 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:
| 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 |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |