Arthritis Knee, Postoperative Nausea, Postoperative Pain
Conditions
Brief summary
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
DRUGDexamethasone
4 mg bid for 4 days
DRUGPlacebo
oral placebo
Sponsors
Henry Ford Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Participants will be randomly assigned to one of two groups, treatment or no treatment. Randomizations will be balanced at random accrual points.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Episodes of Nausea | 3 weeks | — |
| Postoperative Pain | 3 weeks following surgery | Postoperative pain will be collected via visual analog scores |
| Opioid Consumption | 6 months | Opioid consumption will be recorded by participant in assigned journal, morphine equivalence will be recorded |
| Antiemetic Consumption | 6 months | — |
| Postoperative Nausea | 3 weeks following surgery | Postoperative Nausea will be collected via visual analog scores |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient-reported outcome scores (PROMS) | 6 months | — |
| Knee Injury and Osteoarthritis Outcome Score (KOOS) | 6 months | — |
| Postoperative complications | 6 months | Incidence of surgical site infection, acute prosthetic joint infection |
Contacts
Primary ContactJonathan Shaw, M.D.
Outcome results
None listed