Postoperative Pain Outcomes After Use of Bupivacaine-Meloxicam Extended-Release Solution in Robot Assisted Total Knee Arthroplasty: A Prospective Study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 主要终点
- Patient reported outcome measure (Numeric Rating Scale)
研究概览
简要总结
Prospective Cohort of patients who are scheduled for a Robot Assisted Total Knee Arthroplasty (RATKA). A prospective survey of patient reported outcome measures (Numeric Rating Scale) will be obtained postoperatively of 72 hours, as well as at the postoperative opioid consumption after 72 hours.
详细描述
Opioid use is a well-discussed issue in the United States among orthopedic surgeons, as while these drugs are helpful and necessary, they pose the risk of addiction and ultimately should be used as sparingly as possible. By taking a multimodal approach to pain management, this can be successfully achieved. Periarticular injections are currently used to achieve this goal, and 2021 a bupivacaine-meloxicam extended-release periarticular injection (Zynrelef) was introduced and is regularly implemented into RATKAs. Randomized clinical trials found that Zynrelef's use in traditional total knee arthroplasties (TKA) was just as effective as standard periarticular injections in reducing opioid use and pain, but whether Zynrelef works just as well if not better in RATKA is not yet established.
Objectives: (primary and important secondary objectives)
To evaluate the improvement in pain and use of opioids of a patient who received Zynrelef after undergoing RATKA compared to the traditional periarticular injections commonly used. The secondary objective will be documentation of the patient's use of other oral (over-the-counter) OTC pain relievers, such as acetaminophen or NSAIDs (non-steroidal anti inflammatory drugs).
Study Design:
Prospective Cohort Study (double arm)
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females aged 18-89 years
- •Diagnosed with knee osteoarthritis requiring surgical intervention
- •Indicated for unilateral RATKA
排除标准
- •Pediatric, pregnant, or incarcerated patients
- •BMI of more than 45 kg/m2
- •Prolonged opioid use history of >5 mg/day for >1 month
- •History of contralateral TKA <2 years prior to the index TKA
- •Type 1 Hypersensitivity to NSAIDs or local anesthetics
- •Diagnosis of severe renal disease
研究组 & 干预措施
Zynrelef
Periarticular injection of bupivacaine-meloxicam extended release
干预措施: bupivacaine-meloxicam (extended release) (Combination Product)
结局指标
主要结局
Patient reported outcome measure (Numeric Rating Scale)
时间窗: From completion of surgery to 3 days post-op
Self-report of pain using numeric scale. Title: Numeric Rating Scale; Ranges from 0 to 10, where 10 is maximal pain and 0 is no pain at all.
Amount of opioid medications used (measured in morphine milligrams equivalents)
时间窗: From completion of surgery to 3 days post-op
Self-report of opioid medications
次要结局
- Complications and Adverse Events(From completion of surgery to 3 days post-op)
- Amount of oral OTC pain reliever medications used(From completion of surgery to 3 days post-op)
- Amount of oral Over-the-counter (OTC) pain reliever medications used(From completion of surgery to 3 days post-operation)
研究者
Andrew Waligora
Physician
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)