Evaluation of Serratus Posterior Superior (SPS) Block Versus Surgical Intercostal Blockade in Preventing Chronic Post-Thoracotomy Pain After Video-Assisted Thoracoscopic Surgery (VATS): A Randomized, Prospective, Comparative Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Incidence and severity of Chronic Post-Thoracotomy Pain (CPTP)
研究概览
简要总结
This study aims to evaluate the efficacy of ultrasound-guided Serratus Posterior Superior (SPS) block compared to surgeon-administered intercostal blockade in preventing chronic pain at 3, 6, and 12 months following Video-Assisted Thoracoscopic Surgery (VATS).
详细描述
Although VATS is a minimally invasive technique, chronic post-thoracotomy pain (CPTP) remains a significant complication due to intercostal nerve injury. This study investigates whether the preemptive analgesic effect of the SPS block, performed under ultrasound guidance before surgery, reduces the incidence and severity of chronic pain more effectively than standard surgical intercostal blocks. Secondary objectives include assessing acute pain scores (VAS/NRS) within the first 24 hours, total opioid consumption, and duration of hospital stay.
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
- Single (Participant)
盲法说明
The patients will be blind to the study groups.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA physical status I-III.
- •Scheduled for elective unilateral Video-Assisted Thoracoscopic Surgery (VATS).
排除标准
- •History of allergy to local anesthetics.
- •Pre-existing chronic pain syndrome or neuropathic pain.
- •Psychiatric disorders affecting pain assessment.
- •Coagulation disorders.
- •Previous thoracic surgery on the same side.
研究组 & 干预措施
SPS Block Group
SPS Block will be performed at the end of the surgery
干预措施: SPS block (Drug)
Surgical Intercostal Blockade Group
Surgical Intercostal Blockade will be performed at the end of the surgery by the surgeon
干预措施: Surgical Intercostal Blockade. (Drug)
结局指标
主要结局
Incidence and severity of Chronic Post-Thoracotomy Pain (CPTP)
时间窗: Incidence and severity of Chronic Post-Thoracotomy Pain (CPTP) at 3, 6, and 12 months post-surgery.
The primary aim is to compare incidence and severity of Chronic Post-Thoracotomy Pain with McGill Pain Questionnaire (MPQ).
次要结局
- Opioid consumption (Fentanyl PCA)(Changes from baseline opioid consumption at postoperative 1, 2, 4, 8, 16 and 24 hours.)
- Pain scores (Numerical rating scale-NRS)(Changes from baseline pain scores at postoperative 1, 2, 4, 8, 16 and 24 hours)
- Need for rescue analgesia (meperidine)(Postoperative 24 hours period)
- Adverse events(Postoperative 24 hours period)
- Incidence and severity of Chronic Post-Thoracotomy Pain (CPTP)(Incidence and severity of Chronic Post-Thoracotomy Pain (CPTP) at 3, 6, and 12 months post-surgery.)
研究者
Bahadir Ciftci
Principal Investigator
Medipol University