Serratus Anterior Plane Block Versus Standard of Care After Totally Endoscopic Aortic Valve Replacement: a Double-blinded Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Cumulative opioid consumption by patient-controlled intravenous analgesia (PCIA)
研究概览
简要总结
The aim of this study is to assess and compare the efficacy of a serratus anterior plane (SAP) block and our current pain protocol (Patient Controlled Intravenous Analgesia with opioids) in the prevention and treatment of acute postoperative pain after totally endoscopic aortic valve replacement (AVR) surgery.
详细描述
During the last two decades, cardiac surgical techniques changed dramatically. Evidence for good short and long-term outcome after endovascular and minimally invasive procedures is rising. The goal of avoiding sternotomy is earlier patient recovery without compromising safety. Therefore, enhanced recovery after surgery (ERAS) protocols have been implemented to aim for early extubation and ambulation. Analgesic regimens after cardiac surgery did not change significant however. Opioids remain the cornerstone of analgesia in the postoperative cardiac surgical care units, despite known side effects as nausea, constipation and risk for addiction. Neuraxial anesthetic techniques after cardiac surgery have been studied and validated to reduce opioid consumption. Their implementation in clinical practice however remains limited for two reasons. First, heparinization is required for cardiac surgery, which increases the risk neuraxial hematoma after neuraxial anesthesia, leading to deleterious complications as paraplegia. Secondly, neuraxial anesthesia induces orthosympathicolysis, enhancing vasoplegia after cardiac surgery. However, fascial plane blocks in cardiac surgery since peripheral blocks do not induce sympathicolysis and consequences of chest wall hematoma are limited.
In 2013, Blanco described the serratus anterior plane (SAP) block as an analgesic option for chest wall surgery. In this fascial plane block, local anesthetics are injected in the plane beneath the anterior serratus muscle and in the plane between latissimus dorsi and serratus anterior in an ultrasound guided manner. SAP block provides analgesia in dermatomes T2-T9. Recently, successful analgesia after SAP block has been demonstrated for soft tissue chest wall surgery, thoracotomy and rib fractures. No major side effects were reported. More specifically, no sympatholytic effects or chest wall hematoma were observed. However, up to now no prospective studies assessing the analgesic efficacy of SAP block after cardiac surgery are published. Two retrospective studies show conflicting results. Berthoud et al. retrospectively compared SAP block to continuous wound infusion after different types of minimally invasive cardiac surgery (MICS) and found reduced morphine consumption as well as shorter intensive care and hospital length of stay after SAP block. In contrast, Moll et al. found no difference in opioid consumption between SAP block and no block in patients after robotic coronary artery bypass grafting (rCABG). The authors comment they only performed the deep component of the SAP block, and some surgical entry points were outside dermatomes T2-T7.
Totally endoscopic aortic valve replacement (AVR) is a novel minimally invasive cardiosurgical technique. Surgical incision is made anteriorly in intercostal space two on the right hemithorax. Since intercostal space two is innervated by dermatomes T2-T3, somatic analgesia can be obtained with SAP block. In addition with a favorable safety profile and a minimal/non-existent risk of evoking sympatholytic effects, a SAP block may be a suitable analgesic technique to prevent/minimize postoperative pain after totally endoscopic AVR surgery.
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
- •Scheduled for elective aortic valve replacement surgery via right anterolateral thoracotomy
- •Adult patients (minimally 18 years old)
- •EuroScore ii < 3%
- •Bodyweight > 50 kg
排除标准
- •Refusal to participate
- •Inability to communicate due to language or neurologic barriers
- •Inability to control and self-administer opioids with PCIA or to comprehend the NRS pain score due to confusion or learning difficulties
- •Chronic use of opioids
- •Chronic use of analgesic antidepressants and/or antiepileptics
- •History of major trauma or surgery to right chest wall
- •History of chronic pain at right chest wall
- •Allergy to opioids and/or local anesthetics
- •Allergy to acetaminophen
- •Morbid obesity (BMI > 35)
- •Pregnancy
- •Peroperative events compromising early postoperative recovery (aortic dissection, systolic anterior motion of the mitral valve, cardiac tamponade, ..)
研究组 & 干预措施
Experimental group
Patients in the experimental group will receive the serratus anterior plane block combined with postoperative PCIA with Piritramide.
干预措施: Serratus anterior plane block (Procedure)
Experimental group
Patients in the experimental group will receive the serratus anterior plane block combined with postoperative PCIA with Piritramide.
干预措施: PCIA with Piritramide (Drug)
Control group
Patients in the control group will receive postoperative PCIA with Piritramide.
干预措施: PCIA with Piritramide (Drug)
结局指标
主要结局
Cumulative opioid consumption by patient-controlled intravenous analgesia (PCIA)
时间窗: 24 hours after performing the SAP block
Piritramide consumption (mg) will be directly read from the PCIA-system after 24 hours.
次要结局
- Overall patient satisfaction with analgesic therapy(24 hours after performing the serratus anterior plane block at postoperative day 1)
- Time to extubation(Throughout study completion, an average of 7 days)
- Opioid consumption during predetermined time intervals after surgery(Every 4 hours until 24 hours after placement of the SAP block)
- Postoperative pain score in rest(4, 8, 12, and 24 hours after performing the SAP block and at postoperative day 7.)
- Constipation(Until postoperative day 7)
- Hospital length of stay(Through study completion, an average of 7 days)
- Pneumonia(Until postoperative day 7)
- Opioid free patients during hospital length of stay(Through study completion, an average of 7 days)
- ICU length of stay(Until postoperative day 7)
- Quality of recovery after totally endoscopic aortic valve replacement(Postoperative days 2 and 7)
- Opioid free patients first 24 postoperative hours(First 24 hours)
- Postoperative nausea and vomiting (PONV)(24 hours after performing the serratus anterior plane block at postoperative day 1)
- Subcutaneous emphysema(24 hours after performing the serratus anterior plane block at postoperative day 7)
- Duration of vasopressor infusion(Until postoperative day 7)
- Number of patients with new onset perioperative atrial fibrillation (POAF)(Until postoperative day 7)
研究者
Stessel Björn
Principal Investigator
Jessa Hospital
