Evaluation of Liposomal Bupivacaine Compared to Usual Care and Its Effects on Pain for Cardiac Surgery
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- 20% change in opioids use
研究概览
简要总结
Evaluation of Liposomal Bupivacaine Compared to Usual Care and its Effect on Pain for Cardiac Surgery
详细描述
Current standard of care for pain management includes a multimodal approach of peristernal and fifth intercoastal infiltration with 0.25% bupivacaine with epinepherine combined with immediate post operative IV acetaminophen, followed by scheduled oral acetaminophen and supplemental IV and PO narcotics. This practice is beneficial since it controls most of the direct surgical site pain for at least 6 hours, however, after the local anesthetic dissipates, pain is usually managed with the use of opioids combined with scheduled oral acetaminophen.
Opioids are the most commonly used medications to control pain early after surgery because of their high potency. However, their undesirable effects and risk of dependence become limitations.
The Investigators believe Liposomal Bupivacaine would be beneficial in this population due to its quick onset of action and prolonged half-life associated with liposomal formulation ranging from 23.8 to 34.1 hours. The primary endpoint will be a 20% reduction in opioids use.
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)
盲法说明
Patients will be randomized per study coordinator. SOC includes 0.25%bupivacaine with epinephrine at 1cc/kg total dose and the treatment arm will include liposomal bupivacaine 266mg/20ml added to usual dose.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 years old
- •All open heart surgeries from September 1, 2019 - September 30, 2020
- •Able to read, comprehend and sign the informed consent form
排除标准
- •Pregnancy
- •< 18 years old and prisoners
- •Not able to sign informed consent, including patients with an (LAR) legally authorized representative
- •Patients with chronic pain requiring scheduled narcotic use
- •Stage 4 kidney disease, Child Pugh score suggestive of liver cirrhosis/ disease
- •Recent MI within 7 days of scheduled Cardiac surgery
- •Known allergy to Liposomal Bupivacaine or derivative of
- •Have or is currently involved in a Research Study within 30 days of scheduled surgery
研究组 & 干预措施
Exparel
administration of liposomal bupivacaine 266mg/20mL+ 40 mL bupivacaine 0.25% bupivacaine
.
干预措施: Liposomal bupivacaine (Drug)
Exparel
administration of liposomal bupivacaine 266mg/20mL+ 40 mL bupivacaine 0.25% bupivacaine
.
干预措施: 0.25% Bupivacaine with epinephrine (Drug)
Standard of Therapy
administration of 0.25% bupivacaine with epinephrine at 1cc/kg total dose
干预措施: 0.25% Bupivacaine with epinephrine (Drug)
结局指标
主要结局
20% change in opioids use
时间窗: From post operative day of cardiac surgery through length of hospital admission and through study completion, an average of one year.
Record daily narcotic use
次要结局
- Time to extubation(Post operative day of surgery through study completion, an average of 1 year)
- Time to ICU(Post operative day of surgery through study completion, an average of 1 year)
- Total narcotic use on Post op Day 2,3, and 4(Day of cardiac surgery to Post op day 4)
- Major Adverse Cardiac Effects of Liposomal Bupivacaine(Time of peristernal and fifth intercostal infiltration of liposomal bupivacaine through the expected half life associated with liposomal formulation ranging from 23.8 up to 34.1 hours.)
- Time to Hospital Discharge(Count the number of days from admission for cardiac surgery to day of hospital discharge through study completion , an average of one year)
- Pain Scores on Post op day 2,3 and 4(Post operative day of cardiac surgery through Post operative Day 4)
研究者
Charles Klodell, MD
Cardiothoracic Surgeon
Florida Heart and Lung Institute