Comparing Opioid Consumption Following Total Knee Arthroplasty With The Perioperative Administration of Zynrelef Versus Adductor Canal Block
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Mean Milligram Morphine Equivalents (MME)
研究概览
简要总结
To compare postoperative MME consumption 72 hours after TKA in patients receiving intraoperative periarticular HTX-011 (Zynrelef) instillation versus adductor canal block.
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
- 是
入选标准
- •Patients > 18 years of age
- •Patients undergoing primary, unilateral total knee arthroplasty
- •Ability to provide informed consent
排除标准
- •Individuals under the age of 18
- •Pregnant women
- •Prisoners
- •Adults unable to consent
- •American Society of Anesthesiologists Physical Status score greater than 3
- •Patients taking any of the following medications before surgery:
- •Long-acting opioids within 3 days
- •Any opioids taken within 24 hours
- •Bupivacaine HCL within 5 days
- •Chronic opioid use or patients with known or suspected daily use of opioids for seven or more consecutive days within 6 months before their scheduled surgery
- •Illicit drug use determined by social history
- •Alcohol abuse determined by a CAGE Substance Abuse Screening Tool Score of at least two or greater
- •Patients with a known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to any local anesthetic agent of the amide-type, NSAIDs, or to any of the other components of ZYNRELEF
- •Patients with a history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients
研究组 & 干预措施
Zynrelef (HTX-011) with application procedure
Participants in this group will receive intraoperative analgesia via application of ZYNRELEF (HTX-011) directly into the periarticular tissues at the surgical site following prosthesis implantation and prior to capsule closure. The medication will be applied by the surgeon using sterile technique per manufacturer instructions, targeting the posterior capsule, medial and lateral gutters, and surrounding soft tissues.
干预措施: ZYNRELEF 400Mg-12Mg Extended-Release Solution (Drug)
Adductor canal block (ACB)
Participants in this group will receive a postoperative ultrasound-guided adductor canal block performed by a board-certified anesthesiologist or regional anesthesia-trained provider. The procedure will be conducted under sterile conditions while the patient remains under spinal anesthesia.
干预措施: Ultrasound-Guided Adductor Canal Block (Procedure)
Adductor canal block (ACB)
Participants in this group will receive a postoperative ultrasound-guided adductor canal block performed by a board-certified anesthesiologist or regional anesthesia-trained provider. The procedure will be conducted under sterile conditions while the patient remains under spinal anesthesia.
干预措施: Ropivacaine 0.5% Injectable Solution (Drug)
结局指标
主要结局
Mean Milligram Morphine Equivalents (MME)
时间窗: 12, 16, 20, 24, 48, and 72 hours after surgery
Mean cumulative milligram morphine equivalents (MME) administered at 4, 8, 12, 16, 20, 24, 48, and 72 hours following total knee arthroplasty (TKA). Values will be compared between patients receiving Zynrelef and those receiving adductor canal block (ACB)
次要结局
- Visual Analog Scale (VAS) pain scores(4 hours after surgery and 6 weeks)
- Hospital length of stay measured in hours(7 days)
- Knee range of motion(Within 48 hours of surgery, 6 weeks follow up)
研究者
Colin A. McNamara
Professor of Orthopaedic Surgery
University of Miami