Dexamethasone in Total Knee and Total Hip Arthroplasty

Phase 2

• Conditions: Total Knee Arthroplasty; Total Hip Arthroplasty; Osteoarthritis
• Interventions: Other: 0.9% NaCl Placebo; Drug: Dexamethasone; Drug: LIA Combination Mixture

• Registration Number: NCT02760043
• Lead Sponsor: University Health Network, Toronto

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.

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-04-14
• Study First Submitted QC: 2016-04-29
• Study First Posted: 2016-05-03
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-21
• Last Update Posted: 2017-11-24
• Primary Completion: 2018-10
• Study Completion: 2018-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 314

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saline	LIA Combination Mixture	LIA mixture with the addition of 2mL of 0.9% NaCl Saline.
Saline	0.9% NaCl Placebo	LIA mixture with the addition of 2mL of 0.9% NaCl Saline.
Dexamethasone	LIA Combination Mixture	LIA mixture with the addition of 8mg Dexamethasone.
Dexamethasone	Dexamethasone	LIA mixture with the addition of 8mg Dexamethasone.

Primary Outcome Measures

Name	Time	Method
Cumulative systemic opioid consumption measured as oral morphine mg equivalents at 24 hours postoperatively	3 days - post operative

Secondary Outcome Measures

Name	Time	Method
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
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
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
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

Trial Locations

Locations (1)

Toronto Western Hopspital; 🇨🇦 Toronto, Ontario, Canada