Efficacy And Safety Of Tramadol And Oxycodone Versus Oxycodone Monotherapy For Pain Control After Primary Total Knee And Total Hip Arthroplasty
- Conditions
- Post Operative Pain
- Interventions
- Drug: Tramadol and Oxycodone
- Registration Number
- NCT07153003
- Lead Sponsor
- Mayo Clinic
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 560
- Primary TKA
- Primary THA
- Age > 18 years
- Age < 18 years
- Revision or partial TKA/THA
- Pregnant or breast-feeding women
- Simultaneous bilateral TKA/THA
- Primary TKA/THA due to oncologic reason
- Anaphylaxis to opioids
- Renal or liver failure
- Prior opioid use disorder/ substance use disorder
- Opioid use within 3 months prior to surgery
- Patients needing a translator and those with dementia or other cognitive deficits
- Patients taking Monoamine Oxidase Inhibitor (MOAI) medications (phenelzine, tranylcypromine) or benzodiazepine medications (alprazolam, diazepam, lorazepam, etc)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Oxycodone Only Oxycodone Patient's will be prescribed only Oxycodone for post operative pain management. Multimodal Pain Control Tramadol and Oxycodone Patients will be prescribed Tramadol and Oxycodone for post operative opioid pain relief.
- Primary Outcome Measures
Name Time Method Cumulative opioid consumption during the first 30 days 30 days Total amount of opioid medication taken for the first 30 days following surgery, reported in milligrams (mg)
- Secondary Outcome Measures
Name Time Method Cumulative opioid consumption during the first 90 days 90 days Total amount of opioid medication taken for the first 90 days following surgery, reported in milligrams (mg)
Postoperative opioid refills within 90 days 90 days Total number of opioid medication refills within 90 days post surgery
Number of unused opioid pills 90 days Total number of unused opioid pills unused after 90 days
Change in Visual Analogue Scale (VAS) pain scores Daily for 90 days 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.
Number of complications 90 days Total number of complications experienced post-operatively, complications include stiffness, VTE, GI hemorrhage, falls, ileus, dizziness, changes in vision, and miosis.
Number of emesis episodes 90 days Postoperative nausea and vomiting will be measured by total number of emesis episodes
Rate of antiemetic use 90 days Total number of times patients require use of antiemetics for nausea or vomiting
Satisfaction survey scores 90 days 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.
Length of Stay Post-operatively, up to 90 days Total number of days patients stay inpatient
Trial Locations
- Locations (1)
Mayo Clinic in Rochester
🇺🇸Rochester, Minnesota, United States
Mayo Clinic in Rochester🇺🇸Rochester, Minnesota, United States