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Oral Dexamethasone as an Intervention for Postoperative Pain and Nausea Management in Total Knee Arthroplasty

ConditionsArthritis KneePostoperative NauseaPostoperative Pain
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorHenry Ford Health System

About this trial

This study aims to determine if oral dexamethasone provides clinically significant improvement in postoperative outcomes, specifically nausea and pain scores.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

adult patients age 18 and older who will be undergoing joint replacement

Disqualifiers

Patients with uncontrolled diabetes ( HbA1C, >7.5%), impaired hepatic function (Child class, >B), impaired renal failure (Glomerular filtration rate <60 mL/min/1.73 m2), chronic narcotic use, alcohol and/or opioid dependence, patients with a known adverse reaction to corticosteroids, and patients unable to give informed consent.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dexamethasone

    Drug

    4 mg bid for 4 days

  • Placebo

    Drug

    oral placebo

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: Arm B: Oral DexamethasoneExperimental treatment 1 intervention
Group B: Arm A: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Postoperative Pain

Postoperative pain will be collected via visual analog scores

Time frame
3 weeks following surgery
2

Postoperative Nausea

Postoperative Nausea will be collected via visual analog scores

Time frame
3 weeks following surgery
3

Opioid Consumption

Opioid consumption will be recorded by participant in assigned journal, morphine equivalence will be recorded

Time frame
6 months
4

Antiemetic Consumption

Time frame
6 months

Secondary outcomes

1

Postoperative complications

Incidence of surgical site infection, acute prosthetic joint infection

Time frame
6 months
2

Patient-reported outcome scores (PROMS)

Time frame
6 months
3

Knee Injury and Osteoarthritis Outcome Score (KOOS)

Time frame
6 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Henry Ford Health System

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: