Efficacy And Safety Of Tramadol And Oxycodone Versus Oxycodone Monotherapy For Pain Control After Primary Total Knee And Total Hip Arthroplasty: A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- Enrolling By Invitation
- 发起方
- Mayo Clinic
- 入组人数
- 560
- 试验地点
- 1
- 主要终点
- Cumulative opioid consumption during the first 30 days
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary TKA
- •Primary THA
- •Age > 18 years
排除标准
- •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)
研究组 & 干预措施
Oxycodone Only
Patient's will be prescribed only Oxycodone for post operative pain management.
干预措施: Oxycodone (Drug)
Multimodal Pain Control
Patients will be prescribed Tramadol and Oxycodone for post operative opioid pain relief.
干预措施: Tramadol and Oxycodone (Drug)
结局指标
主要结局
Cumulative opioid consumption during the first 30 days
时间窗: 30 days
Total amount of opioid medication taken for the first 30 days following surgery, reported in milligrams (mg)
次要结局
- Cumulative opioid consumption during the first 90 days(90 days)
- Postoperative opioid refills within 90 days(90 days)
- Number of unused opioid pills(90 days)
- Change in Visual Analogue Scale (VAS) pain scores(Daily for 90 days)
- Number of complications(90 days)
- Number of emesis episodes(90 days)
- Rate of antiemetic use(90 days)
- Satisfaction survey scores(90 days)
- Length of Stay(Post-operatively, up to 90 days)
研究者
Charles P. Hannon
Principal Investigator
Mayo Clinic