Dexamethasone in Total Knee Arthroplasty

Rush

Status and phase: Completed; Phase 4

Conditions: Total Knee Arthroplasty

Treatments: Drug: Dexamethasone 16mg; Drug: Dexamethasone 4mg; Drug: Dexamethasone 8 Mg/mL Injectable Suspension

Study type: Interventional

Funder types: Other

Identifiers

NCT05018091

21081102

Details and patient eligibility

About

The purpose of this study is to determine the most efficacious and safest dexamethasone dose given intraoperatively during total knee arthroplasty that reduces postoperative opioid consumption and pain, improves postoperative nausea and vomiting, and minimizes postoperative complications.

Full description

Study design: Prospective randomized controlled trial

Scientific Background: In contemporary total joint arthroplasty (TJA), multimodal anesthesia and analgesia is used to improve postoperative pain, reduce opioid consumption, and minimize complications after surgery such as postoperative nausea and vomiting.1-3 Multiple medications with varying mechanisms of action are used at different time points throughout the perioperative period to modulate different pain receptors. Corticosteroids are a medication commonly utilized intraoperatively as part of contemporary multimodal protocols.

Corticosteroids are frequently used in TJA due to their potent anti-inflammatory and anti-emetic properties. Several studies have demonstrated that corticosteroids reduce postoperative nausea and vomiting as well as postoperative pain and opioid consumption.4-6 However, the optimal medication, dose, and number of doses of corticosteroid that should be administered in the perioperative period remain unknown. In addition, it remains unclear if corticosteroids can be safely used in patients with diabetes mellitus or if corticosteroids increase the risk of postoperative complications such as periprosthetic joint infection. Thus, the purpose of our study is to determine the most efficacious and safest dose of corticosteroids that should be administered intraoperatively during TJA.

Enrollment: 404 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age > 18 years
• Primary total knee arthroplasty
• Patients staying at least one night in the hospital after surgery

Exclusion criteria

• Same day discharge Age < 18 years Revision or partial total knee arthroplasty Corticosteroid use within 3 months prior to surgery Inflammatory arthritis Current systemic fungal infection Renal or liver failure Prior adverse reaction to corticosteroid Primary TKA requiring hardware removal

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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404 participants in 3 patient groups

Group 1

Active Comparator group

Description:

4mg intravenous dexamethasone, administered shortly after induction of anesthesia

Treatment:

Drug: Dexamethasone 4mg

Group 2

Active Comparator group

Description:

8mg intravenous dexamethasone, administered shortly after induction of anesthesia

Treatment:

Drug: Dexamethasone 8 Mg/mL Injectable Suspension

Group 3

Active Comparator group

Description:

16mg intravenous dexamethasone, administered shortly after induction of anesthesia

Treatment:

Drug: Dexamethasone 16mg