Parasternal Intercostal Nerve Block in Post-Cardiac Surgery Patients: A Randomized, Controlled Trial of Extended-release Liposomal Bupivacaine (Exparel) Versus Placebo
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 79
- 试验地点
- 1
- 主要终点
- Median Cumulative Morphine Equivalent
研究概览
简要总结
Exparel is a new local analgesic (numbing medication) that is intended to be longer acting than currently available local analgesics. The purpose of this study is to determine whether use of Exparel to numb the nerves along the breastbone after open heart surgery, will decrease pain and pain medication use after surgery.
详细描述
This is a Phase 2, single-institution, randomized, double-blind, parallel-group, placebo-controlled trial of patients undergoing a median sternotomy for primary cardiopulmonary bypass grafting (CABG) surgery.
78 subjects (39 per treatment arm) will be randomized in a 1:1 ratio to receive a single-dose, parasternal nerve block with either 266 mg Exparel or placebo (0.9% normal saline solution). The nerve blocks will be performed under direct visualization at the end of surgery, just prior to sternal closure.
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
- Quadruple (Participant, Care Provider, Investigator, 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
- 否
入选标准
- •≥ 18 years old
- •non-emergent coronary artery bypass grafting surgery (on and off pump)
- •median sternotomy
排除标准
- •Concomitant cardiac procedures (e.g. aortic valve repair/replacement, mitral valve repair/replacement, aortic root replacements).
- •Redo sternotomy.
- •< 50 kg (Exparel® is currently only approved in patients > 50 kg).
- •Pregnant or nursing
- •History of alcohol, narcotic or illicit drug abuse
- •Participation in another study evaluating investigational medications within the past 30 days
- •Taking narcotic analgesics within 3 days pre-operatively or perioperative stress-dose steroids.
- •Chronic non-cardiac pain (e.g. lower back pain, fibromyalgia) requiring narcotic analgesics.
- •Pre-operative mild liver insufficiency as defined by liver function tests [(i.e. alanine aminotransferase (ALT), aspartate aminotransferase (AST)] ≥ 1.5 times the upper limit of normal (ULN: ALT: 0-35 U/L, AST: 0-35 U/L, Alk Phos 35-105 U/L, Total bilirubin: 0-1.2 mg/dL)
- •Pre-operative mild renal insufficiency (Cr ≥ 1.5 mg/dL)
- •Allergy to amide-type anesthetics
- •Recurrent ventricular arrhythmias, low cardiac output requiring inotrope and/or intra-aortic balloon pump support, left ventricular ejection fraction < 30% at time of pre-operative screening/evaluation.
- •Unable to provide informed consent or unable to understand how to use pain rating scales.
- •Inability to understand or operate the patient-controlled analgesia (PCA) machine.
研究组 & 干预措施
Exparel
266 mg Exparel, single-dose injection.
干预措施: Exparel (Drug)
Placebo
0.9% Normal saline, single-dose injection.
干预措施: Placebo (Drug)
结局指标
主要结局
Median Cumulative Morphine Equivalent
时间窗: Outcome was measured at 1,2,4,8,12,24,36,48,60, and 72 hours post intercostal nerve block.
The cumulative opioid requirement is reported as morphine equivalent. The total amount of narcotics required by the subjects in the Exparel group and placebo group were measured at 1,2,4,8,12,24,36,48,60, and 72 hours post-injection of Exparel or 0.9% normal saline. The amounts were analyzed and are reported as morphine equivalents.
Median Pain Levels
时间窗: Outcome was measured at 1,2,4,8,12,24,36,48,60, and 72 hours post intercostal nerve block.
The pain scores of the subjects in the Exparel group and placebo group were measured at 1,2,4,8,12,24,36,48,60, and 72 hours post-injection of Exparel or 0.9% normal saline. The pain scores were reported on a scale of 0 - 10. 0 being no pain. 10 being the worst pain.
次要结局
- Time to First Bowel Movement (Days)(35 days)
- Hospital Length of Stay (Days)(25 days)
- Time to Extubation (Hours)(77 hours)
- ICU Length of Stay (Hours)(135 hours)
- Time to Return to Work or Daily Activities(36 days)
研究者
Peter A Knight
Professor, Cardiac Surgery
University of Rochester