Ultrasound-Guided Erector Spinae Plane Block Versus Intravenous Nalbuphine for Postoperative Analgesia After Video-assisted Thoracoscopy in Obese Patients: A Randomized Controlled Trial of Safety and Effectiveness
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Time to first rescue analgesia during the first 24 hours postoperative using Verbal Numerical Rating Scale (VNRS)
研究概览
简要总结
2.1. Study population and setting: This prospective, randomized, controlled clinical trial will be conducted at the thoracic surgery operation room, cardiothoracic surgery building, Zagazig University Hospitals, from July 2025 to December 2025.
Our study included 102 patients who are planned for video-assisted thoracoscopy. Cases will randomly divided into two groups: Erector Spinae Plane Block (ESPB) and the control group, comprising 51 patients each. Inclusion criteria also include: American Society of Anesthesiologist (ASA) status of II and III, age between 21 years and 60 years, and BMI (body mass index) between 30 and 40 kg/ m2. Patients who will be excluded from the present study included: BMI <30 or > 40 kg/ m2, chronic pain with regular use of either opioids or gabapentinoids during the 2 weeks before surgery, history of thoracic surgery on the same side, anticipated high risk of conversion to thoracotomy, taking anticoagulation, suffering from any bleed¬ing disorders, known allergy to local anesthetics, nalbuphine or fentanyl, active infection at the injection site, pre-existing neurological or psychiatric illness, severe cardiovascular disease, liver failure, renal failure (estimated glomerular filtration rate less than 15 ml min), and pregnancy.
Patients will be also excluded after randomiza¬tion if they have converted to thoracot¬omy, severe intra- or postoperative blood loss >1000cc, required postoperative mechanical ventilation, or a technical difficulty in the ESPB performance.
2.2. Randomization and allocation Patients will be randomized in a one-to-one ratio and assigned to either the ESPB (group A) or control group (group B) (Fig. 1). Randomization allocations will be kept in sealed opaque covers and only opened by the investigator immediately prior to the ESPB, which will be performed in a holding area before entry into the block rooms. All blocks will be performed by the same anesthetist using the linear probe of an Ultrasound machine (GE Vivid E95).
详细描述
Introduction The prevention of respiratory complications is a significant issue after thoracic surgery and requires adequate postoperative pain management. Prevention and management of surgery-related pain is essential in VATS, due to high incidence of moderate to severe acute postoperative pain. Apart from non-steroid anti-inflammatory agents and intravenous opioids, local anesthetic infiltration of incision sites, preemptive analgesia methods, and regional anesthesia techniques play a role in multimodal analgesia.
Guidelines for enhanced recovery after lung surgery recommend the use of regional analgesia and opioid-sparing analgesia to facilitate early mobilization and reduce the risk of pulmonary complications.
Thoracic epidural analgesia (TEA) is recognized as the gold standard for acute postoperative pain relief after thoracotomy, multiple authors have suggested it is too invasive for VATS.
The Paravertebral Block (PVB) is a widely utilized regional anesthesia technique for video-assisted thoracoscopic surgery (VATS). However, it is still regarded as an invasive procedure, raising concerns about its benefit-risk balance. As a neuraxial technique, it carries certain risks, including the potential for spinal hematoma and epidural abscess.
In recent years, innovative chest wall blocks like the Erector Spinae Plane Block (ESPB) have been introduced to enhance pain relief while minimizing the risk of damaging nearby vital structures. The ultrasound landmarks for the ESPB are easier to locate and situated farther from the neuraxis and pleura compared to the epidural and paravertebral spaces. This characteristic makes it a potentially less invasive option and offers a simpler and safer alternative for pain management after video-assisted thoracoscopic surgery (VATS). Originally described for managing thoracic neuropathic pain, the ESPB has emerged as an effective regional anesthesia technique for preventing postoperative pain in VATS.
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
- Double (Participant, Investigator)
盲法说明
double-blinded
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologist (ASA) status of II and III,
- •age between 21 years and 60 years
- •BMI (body mass index) between 30 and 40 kg/ m2
排除标准
- •BMI <30 or > 40 kg/ m2
- •chronic pain with regular use of either opioids or gabapentinoids during the 2 weeks before surgery
- •history of thoracic surgery on the same side
- •anticipated high risk of conversion to thoracotomy
- •taking anticoagulation
- •suffering from any bleeding disorders
- •known allergy to local anesthetics, nalbuphine or fentanyl
- •active infection at the injection site
- •pre-existing neurological or psychiatric illness
- •severe cardiovascular disease
- •liver failure
- •renal failure (estimated glomerular filtration rate less than 15 ml min)
- •pregnancy
研究组 & 干预措施
group A
received ultrasound-guided Erector Spinae Plane Block (ESPB) in addition to multimodal analgesia
干预措施: Erector Spinae (ESP) Block with Bupivacaine (Marcaine®) (Procedure)
group B
who received conventional postoperative intravenous analgesia in the form of nalbuphine without ESPB (control group).
结局指标
主要结局
Time to first rescue analgesia during the first 24 hours postoperative using Verbal Numerical Rating Scale (VNRS)
时间窗: 6 months
Verbal Numerical Rating Scale (VNRS) is a clinical tool used to assess the intensity of pain by categorizing patient responses into ordered descriptive terms such as "no pain," "mild," "moderate," or "severe When VNRS was more than 3, at that time we will give rescue nalbuphine in a dose of 5 mg
次要结局
未报告次要终点