Regional Blockade of the Sternum With Liposomal Bupivacaine Prior to Incision Decreases Opioid Use in Patients Undergoing Cardiac Surgery (Sternal Block)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Total Postoperative Opioid Measured in Milligram Morphine Equivalent (MME) at 72 Hours
研究概览
简要总结
The purpose of this study is to find out what effects (good and bad) that the study medicine called "liposomal bupivacaine" has on subjects that are undergoing a sternotomy. Liposomal bupivacaine solution, is a drug that the doctor will inject before they make the cut through patient's breastbone (sternotomy). Normally pain medicine like this is given right before the surgeon closes up the patient's breastbone, at the end of the surgery. For this study, they want to see if giving the medicine before they make the cut into the patient's breastbone helps their pain. They also want to find out if patients feel less pain after surgery with the study drug than they do with saline and possibly decrease the need for pain medicine. Subjects will be in the study for about 72 hours or until they are discharged from the hospital.
详细描述
Background:
Prolonged and excessive narcotic usage in the postoperative setting has been linked to multiple complications. Use of complimentary pain management techniques such as regional analgesia can reduce postoperative pain and narcotic usage. This can enhance patient recovery and improve quality of life in the immediate postoperative period. Previous research investigating the benefits of local analgesia during cardiac surgery have been limited by the sparse amount of single-center randomized controlled trials, particularly evaluating the use of para-sternal injections.
Of the available studies, the use of local analgesia injections compared to controls has led to improved pain scores and overall decreased perioperative opioid usage. Studies have shown this efficacy using 0.2% ropivacaine, 0.75% ropivacaine, and 0.53% liposomal bupivacaine all compared to control groups receiving normal saline injections in the para-sternal area. These studies all used injections just prior to sternal closure and no significant evidence is available for the use of ultrasound-guided regional block of the sternum prior to surgical incision. Injection of analgesia prior to surgical incision has been shown to decrease postoperative pain compared to injection after surgical closure.
We hypothesize that injection of 1.3% liposomal bupivacaine and 0.5% bupivacaine (20mL dose) as a sternal block prior to surgical incision will lead to decreased pain and opioid usage in the intraoperative and postoperative setting for patients undergoing upper mini- and median sternotomy compared to controls.
Methods:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The surgeon, coordinator and anesthesiologist on the case are blinded to the block drug. A 2nd (unblinded) anesthesiologist performs the block on the patient.
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 greater than 18 years
- •Undergoing a surgical procedure through mini- or full sternotomy.
排除标准
- •Clinical instability
- •Allergic to liposomal bupivacaine solution or any of its ingredients
- •Maximum-allowed dosage of local analgesia will be exceeded by the injection amount of liposomal bupivacaine used in this study (<50 kg).
- •Pregnant or nursing
- •Chronic home opioid usage
- •Left Ventricular Ejection Fraction (LVEF) < 30%
- •Low cardiac output requiring mechanical or inotropic support
- •End-stage renal disease
研究组 & 干预措施
Liposomal Bupivacaine Block
Liposomal Bupivacaine (1.3%) solution (20 mL dose). This solution has demonstrated increased efficacy in prolonged analgesia following injection. This solution will be injected as an ultrasound-guided subpectoral interfacial plane block.
干预措施: Liposomal bupivacaine (Drug)
Saline Block
Normal saline (0.9%) will be used as the control solution for patients not receiving the liposomal bupivacaine solution. Injection procedure of this solution will be identical to that of the liposomal bupivacaine solution.
干预措施: Normal Saline Flush, 0.9% Injectable Solution_#1 (Drug)
结局指标
主要结局
Total Postoperative Opioid Measured in Milligram Morphine Equivalent (MME) at 72 Hours
时间窗: Up to 72 hours post-op
The amount of opioid medications used will be recorded during the routine postoperative course.
Intraoperative Opioid Usage Measured in Milligram Morphine Equivalent (MME)
时间窗: During surgery, up to 7 hours
To demonstrate decreased intraoperative opioid usage in the treatment group compared to controls
次要结局
未报告次要终点