NCT02760043

Dexamethasone in Total Knee and Total Hip Arthroplasty

Does the Addition of Dexamethasone to a Local Infiltration Analgesia Mixture Improve Functional Outcomes Following Total Joint Arthroplasty?

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 314 (estimated)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Total Knee Arthroplasty
• Total Hip Arthroplasty
• Osteoarthritis

Interventions

Type	Name	Description
DRUG	Dexamethasone	8mg (2mL) of Dexamethasone added to standard LIA mixture
OTHER	0.9% NaCl Placebo	2mL of 0.9% NaCl placebo (saline) added to standard LIA mixture
DRUG	LIA Combination Mixture	150mL 2% Ropivacaine, 30mg Ketorolac and 0.6mg of Epinephrine

Timeline

• Start date: 2016-04-01
• Primary completion: 2018-10-01
• Completion: 2018-10-01
• First posted: 2016-05-03
• Last updated: 2017-11-24

Locations

1 site across 1 country: Canada