Effect of Early Versus Late Surgical Intercostal Block on Postoperative Pain Relief Following Video-Assisted Thoracic Surgery (VATS): a Randomised, Double-blind Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Postoperative pain intensity during the first 24 hours following video-assisted thoracoscopic surgery (VATS) using the Visual Analog Scale (VAS)
研究概览
简要总结
Video-assisted thoracoscopic surgery (VATS) is associated with significant postoperative pain despite lower morbidity compared with thoracotomy. Adequate pain management is essential within Enhanced Recovery After Surgery (ERAS) pathways to preserve respiratory function and facilitate postoperative recovery. Surgical intercostal block performed under direct vision is a simple and effective regional analgesic technique commonly used following VATS. However, the optimal timing of intercostal block administration during surgery remains uncertain.
This prospective randomized double-blind study will compare surgical intercostal block performed at the beginning versus the end of the surgical procedure. The study aims to evaluate the effect of block timing on postoperative pain intensity and postoperative opioid consumption. The results may help optimize multimodal analgesic strategies in patients undergoing thoracic 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
- •Age ≥ 18 years
- •Scheduled for single-port or two-port video-assisted thoracoscopic surgery (VATS).
- •ASA classification 1 to 3
- •Able to understand the study, describe their pain and provide valid informed consent
排除标准
- •Neurological or psychiatric conditions that compromise the reliable assessment of pain(dementia, cognitive impairment, severe communication disorders)
- •Chronic opioid use or regular use (> 3 months) of strong analgesics for chronic pain
- •History of allergy or known hypersensitivity to local anaesthetics
- •Coagulopathy or anticoagulant therapy precluding the safe performance of an intercostal block
- •Local infection at the injection site or active systemic infection
- •Bilateral thoracic surgery or intraoperative conversion to thoracotomy
- •Second surgery at the same site.
- •Current pregnancy or breastfeeding
- •Inability to understand postoperative instructions or a language barrier preventing a validated assessment of pain
- •Simultaneous participation in another clinical trial involving analgesia or thoracic surgery
- •Refusal to participate or withdrawal of consent at any time
研究组 & 干预措施
ICNB before incision
干预措施: Intercostal nerve block before (ropivacaine 0.375%) (Procedure)
ICNB before incision
干预措施: ICNB after (physiological serum) (Procedure)
ICNB at the end of surgery
干预措施: Intercostal Nerve Bloc before (physiological serum) (Procedure)
ICNB at the end of surgery
干预措施: ICNB after (ropivacaine 0.375%) (Procedure)
结局指标
主要结局
Postoperative pain intensity during the first 24 hours following video-assisted thoracoscopic surgery (VATS) using the Visual Analog Scale (VAS)
时间窗: At 24 hours postoperatively
Postoperative pain intensity will be assessed using the Visual Analog Scale (VAS), a patient-reported pain scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores represent greater pain intensity.
Postoperative pain intensity during the first hour following video-assisted thoracoscopic surgery (VATS) using the Visual Analog Scale (VAS)
时间窗: At 1 hour postoperatively
Postoperative pain intensity will be assessed using the Visual Analog Scale (VAS), a patient-reported pain scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores represent greater pain intensity.
Postoperative pain intensity during the first 6 hours following video-assisted thoracoscopic surgery (VATS) using the Visual Analog Scale (VAS)
时间窗: At 6 hours postoperatively
Postoperative pain intensity will be assessed using the Visual Analog Scale (VAS), a patient-reported pain scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores represent greater pain intensity.
Postoperative pain intensity during the first 12 hours following video-assisted thoracoscopic surgery (VATS) using the Visual Analog Scale (VAS)
时间窗: At 12 hours postoperatively
Postoperative pain intensity will be assessed using the Visual Analog Scale (VAS), a patient-reported pain scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores represent greater pain intensity.
次要结局
- Incidence of postoperative complications during hospitalization.(During hospitalization, up to 30 days)
- Postoperative pain intensity during the first 48 hours following video-assisted thoracoscopic surgery (VATS) using the Visual Analog Scale (VAS)(At 48 hours postoperatively)
- Postoperative pain intensity during the first 72 hours following video-assisted thoracoscopic surgery (VATS) using the Visual Analog Scale (VAS)(At 72 hours postoperatively)
- incidence of chronic postoperative pain 3 months after video-assisted thoracoscopic surgery (VATS)(At 3 months after surgery)
- Intraoperative blood pressure stability(During video-assisted thoracic surgery)
- Intraoperative opioid consumption during video-assisted thoracoscopic surgery (VATS).(From induction of anesthesia to the end of surgery)
- Incidence of adverse effects and complications related to intercostal block administration.(From intercostal block administration until hospital discharge, up to 30 days)
研究者
Céline Boudart
MD PhD
Erasme University Hospital