Oral Dexamethasone as an Intervention for Postoperative Pain and Nausea Management in Total Knee Arthroplasty
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dexamethasone, Placebo.
- Who it may be relevant to
- Registry conditions: Arthritis Knee, Postoperative Nausea, Postoperative Pain. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
This study aims to determine if oral dexamethasone provides clinically significant improvement in postoperative outcomes, specifically nausea and pain scores.
Detailed description
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.
Interventions
- Drug Dexamethasone
4 mg bid for 4 days - Drug Placebo
oral placebo
Primary outcome measures
- Postoperative Pain [Time frame: 3 weeks following surgery]
- Postoperative Nausea [Time frame: 3 weeks following surgery]
- Opioid Consumption [Time frame: 6 months]
- Antiemetic Consumption [Time frame: 6 months]
- Episodes of Nausea [Time frame: 3 weeks]
Secondary outcome measures (3)
- Postoperative complications [Time frame: 6 months]
- Patient-reported outcome scores (PROMS) [Time frame: 6 months]
- Knee Injury and Osteoarthritis Outcome Score (KOOS) [Time frame: 6 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT04432259 · 13565