Liposomal Bupivacaine Versus Standard Analgesia in Total Joint Arthroplasty (TJA)
Efficacy of Liposomal Bupivacaine Versus Standard Analgesia in Pain Management of Total Joint Arthroplasty
研究概览
详细说明
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Ohio
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Columbus、Ohio、美国、43214
- OhioHealth Riverside Methodist Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Clinical diagnosis of osteoarthritis
- Elected to undergo primary TKA, THA, or TSA
Exclusion Criteria:
- Age < 18 years
- Pregnant or breastfeeding
- Non-English speaking
- Unable to give informed consent
- Previous open hip, knee or shoulder surgery
- Pre-determined patients discharging to ECF
- Patients with allergies to bupivacaine
- Patients currently taking opioid pain medication
- Patients with contraindication to nerve blocks
- Patients undergoing simultaneous bilateral joint replacement, as this would require >1 dose of liposomal bupivacaine (Exparel®) per patient for each surgical site
- Patients with severe hepatic disease
- Patients with chronic heart disease as defined as a decreased ejection fraction
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
有源比较器:Standard of care analgesia
Total Hip Arthroplasty (THA): All patients will receive a spinal anesthetic using Fentanyl and Bupivacaine Injection into capsular tissue after placement of the acetabular component: 0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline Total Knee Arthroplasty (TKA): All patients will receive a spinal anesthetic using Fentanyl and Bupivacaine All patients will receive an adductor canal block of 0.25% Bupivacaine w/epinephrine 30cc Injection into posterior capsule of the knee: 0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline Total Shoulder Arthroplasty (TSA): All patients will receive a standard interscalene block with bupivacaine followed by indwelling catheter insertion with ropivacaine infusion to be left in place for two days. |
其他名称:
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实验性的:Liposomal bupivacaine
THA: Standard of care analgesia, PLUS 266 mg of liposomal bupivacaine. Anterior capsule Inferior capsule Posterior capsule Short external rotator Gluteus maximus Subcutaneous tissue TKA: Standard of care analgesia, PLUS 266 mg of liposomal bupivacaine. Posterior knee capsule Anterior femoral periosteum Anterior tibial periosteum Subcutaneous tissue Pericapsular meniscal tissue TSA: All patients will receive a standard interscalene block with bupivacaine PLUS 266 mg of liposomal bupivacaine. Posterior capsule Rotator cuff Subscapularis Humeral periosteum Subcutaneous tissue Deltopectoral muscle |
其他名称:
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
Length of Stay in Hospital (Days)
大体时间:Participants were followed for the duration of hospital stay, an expected average of 3 days
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Participants were followed for the duration of hospital stay, an expected average of 3 days
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次要结果测量
结果测量 |
大体时间 |
---|---|
Time to Post-operative Rescue Opioids (Hours)
大体时间:Immediately following discharge from operating room until the participant was discharged from the hospital, an expected average of 3 days
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Immediately following discharge from operating room until the participant was discharged from the hospital, an expected average of 3 days
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Readmission or Emergency Department (ED) Visit Due to Pain Control Within 30 Days
大体时间:Date of discharge through 30 days following discharge
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Date of discharge through 30 days following discharge
|
合作者和调查者
赞助
调查人员
- 首席研究员:Deborah Napier, BSN,RN,MA、OhioHealth
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
- 关节疾病
- 肌肉骨骼疾病
- 风湿性疾病
- 关节炎
- 骨关节炎
- 骨关节炎,膝盖
- 骨关节炎,髋关节
- 药物的生理作用
- 肾上腺素能药物
- 神经递质药物
- 药理作用的分子机制
- 中枢神经系统抑制剂
- 自主代理
- 周围神经系统药物
- 止痛药
- 感觉系统代理
- 麻醉剂,静脉内
- 麻醉剂,一般
- 麻醉剂
- 抗炎药
- 抗肿瘤药
- 糖皮质激素
- 荷尔蒙
- 激素、激素替代品和激素拮抗剂
- 抗肿瘤药,激素
- 神经保护剂
- 保护剂
- 肾上腺素能α激动剂
- 肾上腺素激动剂
- 镇痛药,阿片类药物
- 毒品
- 佐剂,麻醉
- 麻醉剂,局部
- 支气管扩张剂
- 抗哮喘药
- 呼吸系统药物
- 肾上腺素能β受体激动剂
- 拟交感神经药
- 血管收缩剂
- 散瞳
- 琥珀酸甲泼尼龙
- 芬太尼
- 布比卡因
- 罗哌卡因
- 吗啡
- 肾上腺素
其他研究编号
- OH1-14-00529
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
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