Ropivacaine Plasma Concentrations After Fascial Blocks in Elective Cardio-thoracic and Abdominal Surgery: an Observational, Monocentric Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Incidence of systemic toxicity from local anesthetic signs and symptoms.
研究概览
简要总结
Primary aim: observe the incidence of systemic toxicity from local anesthetic (LAST) after performing fascial blocks in patients undergoing elective cardio-thoracic and abdominal surgery.
Secondary aim: describe the pharmacokinetic profile of the local anesthetic (ropivacaine) and assess peri-procedural complications, post-operative pain and opiate consumption in the first 24 hours.
详细描述
Loco-regional anesthesia (LRA) procedures have acquired, in recent years, increasing importance in the peri-operative control of pain in the field of cardio-thoracic and abdominal surgery. To date, they are recognized as part of the multimodal analgesia underlying the Enhanced Recovery After Surgery (ERAS) protocols as they have demonstrated a better efficacy in post-operative pain control than the use of opiates alone and allow a significant reduction in the use of opioids in the postoperative period.
The advent of ultrasound-guided LRA procedures has led to the development of numerous fascial blocks, which involve the injection, at the level of the muscle-fascial planes, of an abundant volume of low-concentration local anesthetic to allow spread to adjacent nerve structures. The fascial blocks represent a valid alternative to epidural analgesia for the control of postoperative pain in the thoracoabdominal area, as they are characterized by a rapid learning curve and a lower risk of periprocedural complications compared to neuraxial anesthesia procedures.
The main chest wall nerve blocks used in clinical practice include the pectoral nerve block (PECS1 and PECS2) and serrate anterior plane block (SAP) at the level of the anterior chest wall; the spinal erector plane (ESP) block and the paravertebral block at the level of the posterior thoracic wall.
LRA techniques also play a fundamental role in the field of abdominal surgery, especially in the context of multimodal analgesia, aiming to reduce consumption and, consequently, the secondary side effects of the use of opioids.
In the case of laparotomic major abdominal surgery, the use of epidural analgesia has been shown to be effective in reducing post-operative pain, opioid consumption, and recovery of gastrointestinal function, but has not shown a significant reduction in the duration of hospitalization and of post-operative complications.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients undergoing elective cardio-thoracic and abdominal surgery with indications for the execution of fascial block
- •Signature of the informed consent form.
排除标准
- •Lack of informed consent form.
- •Previous neuropsychiatric pathologies or neuropathies of the back / trunk
- •Severe renal insufficiency (GFR <30ml / min)
- •Severe hepatic insufficiency or alteration of liver enzymes
- •Contraindications to LRA procedures (injection site infection, coagulopathy, allergy / hypersensitivity to local anesthetics)
- •Pregnancy
- •Hypoalbuminemia
- •Hospitalization in intensive care and / or post-operative sedation> 24 hours
结局指标
主要结局
Incidence of systemic toxicity from local anesthetic signs and symptoms.
时间窗: 24 hours after surgery
The typical presentation of LAST usually begins with prodromal symptoms and signs, such as perioral numbness, tinnitus, agitation, dysarthria, and confusion. These may be followed by more severe central nervous system (CNS) derangements such as seizures and coma.
次要结局
- Anesthesia effectiveness(Immediately after fascial block)
- Ropivacaine concentration(180 minutes from the fascial block execution)
- Ropivacaine latency time(180 minutes from the fascial block execution)
- Post-operative pain(24 hours after awakening)
- Opioid requirement(24 hours after awakening)
研究者
Luca Brazzi
Full Professor, Director
University of Turin, Italy