Postoperative Pain and Analgesic Requirements After Preoperative Methadone for Primary Total Knee Arthroplasty, a Prospective, Randomized Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Daily Opioid Use
研究概览
简要总结
The goal of this prospective, randomized study is to compare the outcomes of two cohorts of patients undergoing primary Total Knee Arthroplasty (TKA) and to determine whether a single dose of methadone administered preoperatively is effective at reducing postoperative opioid usage and postoperative pain versus a control group of patients receiving standard intraoperative opioids only for primary TKA.
The main questions it aims to answer are:
- What is the efficacy of a single preoperative dose of methadone in reducing opioid consumption and postoperative pain in primary total knee arthroplasty?
- Will the study results demonstrate the effectiveness and safety of a single preoperative dose of methadone (10 mg) in primary total knee arthroplasty in reducing postoperative opioid usage while maintaining a similar or better level of pain control when compared to a standard pain control regimen? Researchers will compare Methadone to a standard pain control regimen (Oxycodone) to see if Methadone is equivalent or more effective at reducing opioid consumption and postoperative pain in primary total knee arthroplasty
Participants will:
- be randomized into one of two groups
- undergo a primary TKA
- complete a tracking sheet documenting daily pain medicine usage and VAS pain level for the first 14 days following the TKA
- return to office at 2 weeks and 6 weeks postop for follow-up
- complete additional questionnaires at 2 weeks and 6 weeks postop
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
盲法说明
Clinical staff other than the anesthesia providers
入排标准
- 年龄范围
- 21 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient age is 21-89 at time of surgery
- •Patient is scheduled to undergo a unilateral primary TKA, secondary to osteoarthritis
- •Patient agrees to participate as a study subject and signs the Informed Consent and Research Authorization document
- •Patient is able to read and speak English.
排除标准
- •Patient is under the age of 21
- •Patient's primary diagnosis is not osteoarthritis
- •Patient is unable to read and speak English
- •History of liver or kidney disease,
- •Known or suspected GI obstruction
- •Hypersensitivity to methadone
- •Patients with significant respiratory depression
- •Pregnant or nursing females
研究组 & 干预措施
Methadone Group
Participant receives a one-time preoperative dose of 10 mg of methadone
干预措施: Preoperative Methadone (Drug)
Oxycodone Group
participant receives a one-time preoperative dose of 10 mg of oral oxycodone
干预措施: Preoperative Oxycodone (Drug)
结局指标
主要结局
Daily Opioid Use
时间窗: 2 weeks
Daily Opioid Use as measured in MME recorded daily for the first two weeks following TKA
Total opioid usage over two weeks
时间窗: 2 weeks
total daily opioid usage (as measured in MME) during the first 14 days following TKA
Visual Analogue Scale pain score
时间窗: 2 weeks
Visual Analogue Scale knee pain score (minimum value: 0, maximum value: 10). Higher scores equate to a worse outcome (a score of zero = pain free).
次要结局
- Discharge location(2 weeks)
- Hospital Length of Stay(Up to 2 weeks)
- Two and six-week narcotic refill(6 weeks)
- Knee Injury and Osteoarthritis Outcome Score, Joint Replacement score(preoperatively and 6 weeks (± 2 weeks) postoperatively)
- ROM(preoperatively, 2 weeks and 6 weeks (± 2 weeks) postoperatively)
研究者
Arthur Malkani
Orthopedic Surgeon
University of Louisville