The purpose of this study is to evaluate the effectiveness and safety of tramadol and oxycodone therapy in comparison to oxycodone alone as part of a multimodal pain regimen to reduce postoperative opioid consumption, pain, minimize adverse events and complications for primary total knee arthroplasty (TKA) and primary total hip arthroplasty (THA).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
560
Patients will receive oral Oxycodone only to treat post-operative pain: Oxycodone 5mg * Patients ≤75 years old: 5mg or 10 mg PO every 4 hr as needed * 5 mg for pain rated 4-6 * 10 mg for pain rated 7-10 * Patients \>75 years old and/or sensitive to opioids or sedatives: 2.5mg or 5mg every 4hr as needed * 2.5mg for pain rated 4-6 * 5mg for pain rated 7-10
Patients will receive a combination of Tramadol and Oxycodone to take orally to treat post-operative pain: Tramadol 50mg * Patients ≤75 years old: 50 mg for pain rated 4-6; 100 mg for pain rated 7-10 * Patients \>75 years old and/or sensitive to opioids or sedatives; use 50 mg * Dosing is every 8 hours as needed. Cumulative dose not to exceed 400mg in 24 hours Oxycodone 5mg * Patients ≤75 years old: 5mg or 10 mg PO every 4 hr as needed if still having pain after maximum tramadol administration * 5 mg for pain rated 4-6 * 10 mg for pain rated 7-10 * Patients \>75 years old and/or sensitive to opioids or sedatives: 2.5mg or 5mg every 4 hr as needed if still having pain after maximum tramadol administration * 2.5 mg for pain rated 4-6 * 5 mg for pain rated 7-10
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Cumulative opioid consumption during the first 30 days
Total amount of opioid medication taken for the first 30 days following surgery, reported in milligrams (mg)
Time frame: 30 days
Cumulative opioid consumption during the first 90 days
Total amount of opioid medication taken for the first 90 days following surgery, reported in milligrams (mg)
Time frame: 90 days
Postoperative opioid refills within 90 days
Total number of opioid medication refills within 90 days post surgery
Time frame: 90 days
Number of unused opioid pills
Total number of unused opioid pills unused after 90 days
Time frame: 90 days
Change in Visual Analogue Scale (VAS) pain scores
Pain values reported by participants will be assessed using the 100-mm Visual Analogue Scale (VAS). The VAS line will be 100 mm long with no intermediate delineations. Each end will be marked with "no pain" on the left, and "worst possible pain" on the right. Participants will identify their pain level by indicating a point on the line between each end. That point will be measured from the "No pain" end, and the number of millimeters will be reported as the pain score.
Time frame: Daily for 90 days
Number of complications
Total number of complications experienced post-operatively, complications include stiffness, VTE, GI hemorrhage, falls, ileus, dizziness, changes in vision, and miosis.
Time frame: 90 days
Number of emesis episodes
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Postoperative nausea and vomiting will be measured by total number of emesis episodes
Time frame: 90 days
Rate of antiemetic use
Total number of times patients require use of antiemetics for nausea or vomiting
Time frame: 90 days
Satisfaction survey scores
Patients will be provided with a satisfaction survey 90 days post-surgery. The survey consists of 2 questions rated on a Likert scale measuring understanding and confidence in medication use, and one yes/no question. The Likert scale questions are ranked from "0" - no understanding/low confidence to "10" - full understanding/high confidence. Higher scores indicate greater satisfaction with the prescribed opioid therapy plan.
Time frame: 90 days
Length of Stay
Total number of days patients stay inpatient
Time frame: Post-operatively, up to 90 days