Prospective, Randomized Comparative Study of an Anesthesiological, Ultrasound-Guided "Erector Spinae Plane Block" (ESPB) Versus a Surgical, Thoracoscopically-Guided "Intercostal Nerve Block" (ICNB) in "Video-Assisted Thoracoscopic" (VATS) Procedures, Evaluating Postoperative Analgesic Consumption, Postoperative Pain Perception, and Duration of the Procedure
概览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Sana Klinikum Offenbach
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Assessment of the postoperative analgesic consumption within the first 24 hours after surgery
概览
简要总结
Effective postoperative pain management is essential after thoracic surgery. Insufficient pain control may impair breathing and coughing, increasing the risk of pulmonary complications such as collapsed lungs (atelectasis) or pneumonia.
Although minimally invasive lung surgery (video-assisted thoracoscopic surgery, VATS) is less painful than open surgery, people can still have significant pain after the operation.
The goal of this randomized comparative study is to compare two commonly used regional anesthesia techniques for pain control after VATS in adults.
Researchers will compare an ultrasound-guided erector spinae plane block (ESPB), performed by anesthesiologists, to a thoracoscopically-guided intercostal nerve block (ICNB), performed by surgeons.
Participants will:
- Undergo elective VATS lung resection surgery
- Receive either ESPB or ICNB, according to random assignment
- Have the received amount of analgesics recorded during the first 24 hours
- Have their pain levels assessed at predefined time points after surgery
The main questions this study aims to answer are:
- Does ESPB result in similar analgesic consumption in the first 24 hours after surgery?
- Does ESPB provide similar postoperative pain relief compared to ICNB?
- Is the time needed to perform ESPB similar to ICNB?
详细描述
Effective postoperative pain management is essential after thoracic surgery, as insufficient pain control may impair breathing and increase the risk of pulmonary complications such as atelectasis or pneumonia. Although video-assisted thoracoscopic surgery (VATS) is less invasive than open thoracotomy, patients may still experience significant postoperative pain.
This single-center, prospective, randomized non-inferiority study with two parallel arms compares two commonly used regional anesthesia techniques for perioperative pain management in adult participants undergoing elective VATS lung resections: the Erector Spinae Plane Block (ESPB) and the Intercostal Nerve Block (ICNB). Both techniques have been shown to reduce postoperative pain and opioid consumption. However, existing comparative studies have reported inconsistent results, and direct comparisons are limited by differences in techniques and study design.
After informed consent, participants are randomized preoperatively using a sealed-envelope system to receive either an ultrasound-guided ESPB or a thoracoscopically-guided ICNB.
The ESPB is performed by anesthesiologists before induction of general anesthesia, whereas the ICNB is performed intraoperatively by the surgeon under thoracoscopic visualization. Both interventions use a standardized dose of 25 mL ropivacaine 0.375% prior to the start of the surgical procedure. Perioperative anesthesia and analgesia management are standardized across both groups to ensure comparability and to minimize confounding effects.
The primary objective is to evaluate whether ESPB is non-inferior to ICNB with respect to postoperative analgesic consumption within the first 24 hours after surgery. The non-inferiority margin is defined as 5 mg piritramide within 24 hours. This margin was selected as it corresponds to the upper limit of a commonly used bolus dose in routine clinical practice and represents a clinically meaningful difference.
Secondary objectives include the comparison of postoperative pain perception within the first 24 hours and the duration of the chest wall block procedure. The incidence of postoperative nausea and vomiting (PONV) and procedure-related complications is also assessed.
The sample size calculation is based on the primary non-inferiority endpoint. Estimates of variability were derived from published data on postoperative opioid consumption following VATS. Using a one-sided significance level of 0.025, a statistical power of 90%, and a 1:1 allocation ratio, and accounting for a dropout rate of 10%, a total of 72 participants will be enrolled.
Statistical analysis will follow the non-inferiority design, comparing postoperative analgesic consumption between groups with respect to the predefined margin, while secondary outcomes will be analyzed using appropriate descriptive and inferential statistical methods.
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, 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
- 是
入选标准
- •Provision of written informed consent
- •Adults (≥ 18 years of age)
- •Elective video-assisted thoracoscopic surgery (VATS) for pulmonary resection (e.g., lobectomy, segmentectomy, wedge resection)
排除标准
- •Lack of informed consent
- •Language barrier
- •Pregnancy or breastfeeding
- •Known allergy to local anesthetics used in the study
- •Infection at the injection site(s)
- •History of complex chest wall surgery
- •Revision surgery with a prior operation within the last 6 months
- •Intraoperative conversion to open thoracotomy
- •Chronic pain syndrome
- •Fibromyalgia
研究组 & 干预措施
Anesthesiological, Ultrasound-Guided "Erector Spine Plane Block" (ESPB)
干预措施: Anesthesiological, Ultrasound-Guided "Erector Spine Plane Block" (ESPB) (Procedure)
Surgical, Thoracoscopically-Guided "Intercostal Nerve Block" (ICNB)
干预措施: Surgical, Thoracoscopically-Guided "Intercostal Nerve Block" (ICNB) (Procedure)
结局指标
主要结局
Assessment of the postoperative analgesic consumption within the first 24 hours after surgery
时间窗: First 24 hours after surgery
Postoperative analgesic consumption is recorded during the first 24 hours after surgery. Both total opioid consumption and use of non-opioid analgesics (e.g., metamizole, paracetamol) are documented.
次要结局
- Duration of the chest wall block(Perioperatively)
- Assessment of the postoperative pain perception using the Numeric Rating Scale (NRS) pain scale(First 24 hours after surgery)
研究者
Haitham Mutlak
Head of Department of Anesthesiology
Sana Klinikum Offenbach