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NCT Number: NCT04432259

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

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

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Key information

About this study

Protocols in perioperative pain management during total joint arthroplasty (TJA) have contributed to early discharge after surgery. As practices move to favor ambulatory surgery in total joint arthroplasty changes must be made to postoperative pain and nausea management. Spinal anesthesia has been essential in managing associated ambulatory TJA, however, nausea and vomiting are known detrimental side effects. The use of systemic steroids has also been shown in the literature to reduce pain scores, length of stay, the need for antiemetics, and increase the distance of ambulation without increasing the rate of surgical site infection or prosthetic joint infection. As more same-day total joint replacement is incorporated into practice, an oral alternative may prove beneficial.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Dexamethasone

Drug

4 mg bid for 4 days

Placebo

Drug

oral placebo

Primary outcomes

  1. Postoperative Pain

    Time frame: 3 weeks following surgery

    Postoperative pain will be collected via visual analog scores

  2. Postoperative Nausea

    Time frame: 3 weeks following surgery

    Postoperative Nausea will be collected via visual analog scores

  3. Opioid Consumption

    Time frame: 6 months

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

  4. Antiemetic Consumption

    Time frame: 6 months

  5. Episodes of Nausea

    Time frame: 3 weeks

Secondary outcomes

  1. Postoperative complications

    Time frame: 6 months

    Incidence of surgical site infection, acute prosthetic joint infection

  2. Patient-reported outcome scores (PROMS)

    Time frame: 6 months

  3. Knee Injury and Osteoarthritis Outcome Score (KOOS)

    Time frame: 6 months

Study contacts

Contact information is provided by the study sponsor or research team.

Jonathan Shaw, M.D.

CONTACT

[email protected]

414-405-8544

Sponsors and collaborators

Lead sponsor

Henry Ford Health System

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jun 16, 2020
Registry last updated
Jun 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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