Clinical trial NCT02760043: Dexamethasone in Total Knee and Total Hip Arthroplasty
Official title: Does the Addition of Dexamethasone to a Local Infiltration Analgesia Mixture Improve Functional Outcomes Following Total Joint Arthroplasty?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Total Knee Arthroplasty
Total Hip Arthroplasty
Osteoarthritis
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2016-05-03
Enrollment: 314
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cumulative systemic opioid consumption measured as oral morphine mg equivalents at 24 hours postoperatively
timeFrame: 3 days - post operative
Secondary outcomes:
measure: Analgesic outcomes- pain
timeFrame: 3 days - post operative
measure: Analgesic outcomes- opiate consumption
timeFrame: 3 days - post operative
measure: Analgesic outcomes- TUG test
timeFrame: 3 days - post operative
measure: Analgesic outcomes- Drug side-effects
timeFrame: 3 days - post operative
measure: Short-term physical and performance-based functional outcome measures- in hospital complications
timeFrame: 3 days post operative
measure: Short-term physical and performance-based functional outcome measures- length of stay
timeFrame: 3 days - post operative
measure: Short-term physical and performance-based functional outcome measures- discharge
timeFrame: 3 days - post operatively
measure: Medium-term self-reported functional outcome measures- WOMAC
timeFrame: 3 months- post operative
measure: Medium-term self-reported functional outcome measures- LFES
timeFrame: 3 months- post operative
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto Western Hopspital
state: Ontario
Study officials:
References:
citation: 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.
citation: 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.