Comparing the Efficacy of a Periarticular Instillation of Extended Relief Bupivacaine and Meloxicam With Routine Adductor Canal Blockade for Pain Relief After Primary TKA
试验速览
- 阶段
- 3 期
- 状态
- Enrolling By Invitation
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Postoperative pain
研究概览
简要总结
While a majority of people who undergo TKA have significant long-term improvement in functional ability, many patients may experience significant pain in the early postoperative period, which may adversely impact postoperative rehabilitation and recovery. Traditionally, opioid medications have been used to control postoperative pain. However, there are many risks with using opioid medications, including addiction and overdose, which kills over 48,000 people yearly. In an effort to overcome this, opioid-sparing multimodal analgesia (MMA) regimens have been developed, commonly using nonsteroid anti-inflammatory drugs (NSAIDs), acetaminophen, regional nerve blocks, and local anesthesia.
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 (Outcomes Assessor)
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 or older
- •Patients undergoing primary unilateral TKA
- •Patients receiving spinal anesthesia during primary TKA
- •Patients with adequate cognitive function to participate and complete questionnaires for the study
排除标准
- •Patients undergoing bilateral simultaneous TKA
- •Patients undergoing conversion TKA
- •Patients undergoing unicompartmental knee arthroplasty
- •Patients undergoing patellofemoral arthroplasty
- •Patients with an allergy to NSAIDs or bupivacaine
- •Patients who have a contraindication to the use of NSAIDs
- •Patients who are using chronic anticoagulation, precluding them from using NSAIDs
- •Patients with a history or diagnosis of chronic pain syndrome or complex regional pain syndrome
- •Patients who are determined to be in severe pain from other concomitant conditions
- •Patients with chronic opioid use disorder, defined as patients who are taking more than 20 mg/day morphine milligram equivalents for 30 days consecutively in the 3 months prior to surgery.
研究组 & 干预措施
primary total knee replacement + Zynrelef
Patients undergoing primary total knee replacement with Extended Relief Bupivacaine and Meloxicam (Zynrelef)
干预措施: Zynrelef (Bupivacaine 60 MG / Meloxicam 1.8 MG) Per 2.3 ML Extended Release Solution (Drug)
primary total knee replacement + Zynrelef
Patients undergoing primary total knee replacement with Extended Relief Bupivacaine and Meloxicam (Zynrelef)
干预措施: primary total knee replacement (Procedure)
primary total knee replacement + adductor canal block (ACB)
Patients undergoing primary total knee replacement with routine adductor canal block
干预措施: Bupivacaine HCl 0.5% Injectable Solution (Drug)
primary total knee replacement + adductor canal block (ACB)
Patients undergoing primary total knee replacement with routine adductor canal block
干预措施: primary total knee replacement (Procedure)
结局指标
主要结局
Postoperative pain
时间窗: 14 days
This will be measured by a postoperative Visual Analog Score (VAS) completed by the participant
Opioid consumption
时间窗: 14 days
Participants will be asked to keep a diary of how much pain medication they took after surgery
次要结局
未报告次要终点