Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxycodone Only | Active Comparator | Patient's will be prescribed only Oxycodone for post operative pain management. |
|
| Multimodal Pain Control | Active Comparator | Patients will be prescribed Tramadol and Oxycodone for post operative opioid pain relief. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxycodone | Drug | Patients will receive oral Oxycodone only to treat post-operative pain: Oxycodone 5mg
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 90 days |
| Postoperative opioid refills within 90 days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Charles P. Hannon, MD, MBA | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
Not provided
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Tramadol and Oxycodone | Drug | Patients will receive a combination of Tramadol and Oxycodone to take orally to treat post-operative pain: Tramadol 50mg
Oxycodone 5mg
|
|
Total number of opioid medication refills within 90 days post surgery
| 90 days |
| Number of unused opioid pills | Total number of unused opioid pills unused after 90 days | 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. | 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. | 90 days |
| Number of emesis episodes | Postoperative nausea and vomiting will be measured by total number of emesis episodes | 90 days |
| Rate of antiemetic use | Total number of times patients require use of antiemetics for nausea or vomiting | 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. | 90 days |
| Length of Stay | Total number of days patients stay inpatient | Post-operatively, up to 90 days |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D010098 | Oxycodone |
| D014147 | Tramadol |
| ID | Term |
|---|---|
| D003061 | Codeine |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D004123 | Dimethylamines |
| D008744 | Methylamines |
| D000588 | Amines |
| D008055 | Lipids |
Not provided
Not provided