A Randomized Controlled Trial of ZYNRELEF Versus Standard of Care for Pain Management Following Unilateral Total Knee Arthroplasty
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Total opioid analgesic consumption
研究概览
简要总结
The goal of this randomized controlled trial is to compare opioid medication consumption after surgery for patients who have a total knee replacement.
The main questions it aims to answer are:
- How well does the study drug control pain in the days after surgery?
- Does the study drug reduce the amount of opioid analgesic consumed after surgery?
Participants in the study group will undergo a total knee replacement as planned with their surgeon. In addition, be given the study drug, Zynrelef (combination of bupivacaine and meloxicam).
Researchers will compare the above to a control group who will have a total knee replace only according to usual standards to see if there are any differences in the amount of a type of pain medication (opioid analgesic) consumed in the days following surgery.
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
- Single (Participant)
入排标准
- 年龄范围
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients undergoing primary unilateral total knee arthroplasty [Current Procedural Terminology Code: 27447]
- •Patients with a diagnosis of primary osteoarthritis [ICD-10 codes: M17.0, M17.10, M17.11, M17.12]
- •Varus deformity less than 10 degrees
- •Flexion contracture less than 10 degrees
- •Age 35 - 70 years old
- •Patients who are discharged on the same day after the unilateral total knee arthroplasty procedure
排除标准
- •Inflammatory arthritis
- •Post-traumatic arthritis
- •Valgus deformity
- •Severe varus (> 10 degrees)
- •Severe flexion contracture (> 10 degrees)
- •Overnight or longer hospital stay after surgery
- •Prior surgery on affected knee other than knee arthroscopy for meniscal or cartilage debridement/repair
- •Creatinine > 1.2
- •Chronic Kidney Disease (CKD) stage 3, 4, 5 or end stage renal disease
- •Uncontrolled Diabetes mellitus (Glycated Hemoglobin > 8.0%)
- •Current liver disease
- •Personal history of depression or anxiety disorder
- •Personal history of Deep Venous Thrombosis (DVT) or Pulmonary Embolism (PE)
- •Narcotic or tramadol use within 2 weeks of the planned procedure
- •Allergy to aspirin, NSAIDS, oxycodone, Tylenol, local anesthetics
- •Walking aid for anything other than the operative joint
- •Contraindication for use of the study drug (as specified by the manufacturer):
- •Known hypersensitivity to local amide anesthetics, NSAIDs or study drug components
- •History of asthma, urticaria or other allergic-type reactions to aspirin or other NSAIDs
- •Patients taking the following medications:
- •Amitriptyline
- •Nortriptyline
- •Gabapentin
- •Pregabalin
- •Duloxetine (SNRI)
- •Des-Venlafaxine (SNRI)
- •Cyclobenzaprine
- •Pregnant or lactating females
- •Patients unable to provide informed consent
- •Subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures
研究组 & 干预措施
Intervention
In addition to the standard-of-care arm description, single administration of Bupivacaine-Meloxicam 400 Mg-12 Mg/14 mL Injectable Solution, Extended Release in the surgical site before complete wound closure.
干预措施: Bupivacaine-Meloxicam 400 Mg-12 Mg/14 mL Injectable Solution, Extended Release (Drug)
结局指标
主要结局
Total opioid analgesic consumption
时间窗: 5 days following surgical procedure
Amount of opioid analgesic consumed in the time frame calculated as Morphine Milligram Equivalent (MME).
Change in pain assessment scores
时间窗: Baseline and every 24 hours for 120 hours following surgical procedure
Pain assessment scores using the pain Numeric Rating Scale for pain (NRS). The NRS scale is measured on a scale of 0 - 10, where 0 is no pain and 10 is the most severe pain.
次要结局
- Incidence of major complications(42 days following surgical procedure)