Pharmacokinetics and Pharmacodynamics for Levobupivacaine with and Without Epinephrine After Ultrasound Guided Erector Spinae Plane Block
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Changes in plasma levels levobupivacaine of the group I v/s group II
研究概览
简要总结
Currently there is no standardized management or single technique to manage postoperative pain after Video-assisted thoracic surgery (VATS), there are many options available ranging from intravenous opioids, morphine or fentanyl Patient-controlled analgesia (PCA), peripheral nerve blocks, intercostals, paravertebral and epidural blocks. Erector Spinal Block (ESP), this blocks the ventral and dorsal branch of the unilateral thoracic roots. It corresponds to an interfacial block that produces an extensive multidermatomal sensitive block with a single puncture, covering the anterior, lateral and posterior aspect of the thorax. One of its main advantages would be safety, possible less damage to nerves and pneumothorax, as well as the simplicity of execution of this block. What has positioned it as another analgesic alternative in this type of surgery.
The pharmacokinetic profile that local anesthetics would have when injected into this interfacial compartment has not yet been described, and what the real impact of the use of vasoconstrictor will be in terms of plasma levels and duration of the block.
Our objective is to compare the plasma levels of levobupivacaine achieved after performing an ESP Block with or without epinephrine.
详细描述
Video-assisted thoracic surgery (VATS) is one of the most common procedures performed in thoracic surgery, mainly because it has made it possible to solve many pathologies that previously required a thoracotomy with all the complications that that meant. VATS has been shown to be beneficial for patients, for many reasons such as lower mortality, better postoperative lung function, and shorter stay during hospitalization.
Less invasive procedures such as VATS, where the surgical incision is small and avoids costal resection, produces less postoperative pain when compared to a thoracotomy, this has been objectified by numerous studies that have found lower scores on the numerical verbal scale (NVE) and fewer requirements for pain relievers. Despite the fact that VATS produces less acute postoperative pain (VNS 4-5 on the first postoperative day in VATS vs VNS 6 in thoracotomies), the incidence of chronic postoperative pain ranges from 20 to 47%, which is comparable to thoracotomy, mainly due to damage to the intercostal nerves and inadequate analgesia.
It has been seen that one of the factors associated with the appearance of chronic pain after chest surgery is severe acute pain in the first three postoperative days. Acute pain in VATS is caused by surgical trauma to muscular and bone structures of the thorax, achieving good analgesia is important to maintain adequate respiratory function and avoid complications such as atelectasis, hypoxemia and possible pneumonia.
Currently, there is no standardized management or single technique to manage postoperative pain after VATS, there are many options available ranging from intravenous opioids, morphine or fentanyl Patient-controlled analgesia, peripheral nerve blocks, intercostals, paravertebral and epidural blocks. Each of them with advantages and disadvantages, but without being able to demonstrate a clear superiority between them, both the paravertebral and epidural blocks are the ones that accumulate the most reports in the literature regarding the management of postoperative pain, but at the same time they are not exempt from complications such as technical failure, hypotension and difficulty of the procedure. In addition to documenting a low use of thoracic epidurals in VATS.
At the end of 2016, the description of the Erector Spinal Block (ESP) by Forero was published, it blocks the ventral and dorsal branch of the unilateral thoracic roots. It corresponds to an interfacial block that produces an extensive multidermatomal sensitive block with a single puncture, covering the anterior, lateral and posterior aspect of the thorax. One of its main advantages would be safety, possible less nerve damage and pneumothorax, as well as the simplicity of execution of this block. What has positioned it as another analgesic alternative in this type of 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Indication of VATS
- •Body mass index (BMI) 20-34 kg / m2
排除标准
- •Patients with conversion to thoracotomy
- •History of chronic pain
- •Drug abuse
- •Psychiatric illness
- •Allergic to some of the drugs used in the study
- •Chronic analgesic users
- •History of peripheral neuropathy
- •Who refuse the procedure
研究组 & 干预措施
Group I Epi
The ESP will be performed under ultrasound vision at T5 level, with the patient seated.
Once the ultrasound image is achieved, a 100 mm, 20 G Stimuplex needle will be punctured and a solution of levobupivacaine 0.25% with epinephrine 5 ug/ml completing a volume of 20 ml.
干预措施: Levobupivacaine 0.25% with epinephrine 5 ug/ml (Drug)
Group II no Epi
The ESP will be performed under ultrasound vision at T5 level, with the patient seated.
Once the ultrasound image is achieved, a 100 mm, 20 G Stimuplex needle will be punctured and a solution of levobupivacaine 0.25% without epinephrine completing a volume of 20 ml.
干预措施: Levobupivacaine 0.25% without epinephrine 5 ug/ml (Drug)
结局指标
主要结局
Changes in plasma levels levobupivacaine of the group I v/s group II
时间窗: 5, 10, 20, 30, 60, 90 minutes post block.
To assess the changes in plasma levels of the group I with epinephrine versus the group II without epinephrine.
Sensitive skin extension
时间窗: 15 minutes post-block
Determine the sensitive skin extension of ESP after its performance using pinprick and temperature discrimination using an alcohol swab.
Plasma levels of levobupivacaine
时间窗: 5, 10, 20, 30, 60, 90 minutes post block.
Levobupivacaine plasma levels will be measured using High-performance liquid chromatography.
次要结局
- Pain measured(Every 15 minutes per 2 hours in the PACU and 12 hrs, 24 hrs, 48 hrs during hospitalization)
- Hemodynamics(Every 5 min. Since entering operating room up to end of anesthesia and leaving to recovery room. In average 2 hrs.)
- Heart Rate(Every 5 min. Since entering operating room up to end of anesthesia and leaving to recovery room. In average 2 hrs.)
- Pulse oximetry(Every 5 min. Since entering operating room up to end of anesthesia and leaving to recovery room. In average 2 hrs.)
- Consumption of morphine or its equivalents(During the first 48 hours including intraoperative and postoperative)