SERRATHOR Trial : Analgesic Effect of Serratus Plane Block After Video-Assisted Thoracoscopic Surgery Lobectomy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Total intravenous morphine consumption (mg) in the PACU and department.
研究概览
简要总结
Pain after thoracic surgery remains a challenge for anesthetists. Although VATS for lobectomy is associated with fewer complications compared to thoracotomy, pain after VATS needs to be treated with opioids. Opioids may lead to PONV, respiratory depression, sedation and pruritus. As part of multimodal analgesia and opioids sparing, several local regional techniques has been described: paravertebral block, thoracic epidural analgesia, intercostal block. To date, there is no gold standard for regional anesthesia after VATS.
Serratus plane block is a local regional technique, recently described for analgesia after breast surgery and ribs fracture. In our hospital center, since 2016, we used the Serratus plane block for patients scheduled for lobectomy VATS : a local retrospective trial showed that SPB was associated with a lower consumption of morphine.
The purpose of this randomized controlled double blinded study is to evaluate the analgesic effect of the Serratus plane block, added to a general anesthesia on post operative pain control after VATS lobectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients undergoing lobectomy VATS
- •Older > 18 years
- •Patients who meet criteria of ASA 1 to 3 class
排除标准
- •Patient's refusal to participate in the study
- •Psychiatric disorder (impossibility to collect the informed consent)
- •Patient under juridical protection
- •On going an other study
- •Non balanced epilepsy
- •3 grade auriculo-ventricular heart block without pacing
- •Severe hepatocellular insufficiency
- •Anti arrhythmic treatment : class III of the Vaughan William's classification
- •Pregnant patient or/and breastfeeding
- •History of opioid abuse
- •Allergy to local anesthetic drug or opioids
研究组 & 干预措施
Placebo Block - Control Group
Patients will receive a placebo injection with 0,5 mL/kg of sterile normal solution. Under ultrasonography assistance, placebo will be injected at the fifth rib in the midaxillary line, either superficial to the serratus anterior muscle or deep underneath the muscle.
Anesthesiologists, and all the nurses and caring staff involved in this study will be blinded. Solutions of sterile saline will be prepared identically by the central pharmacy, without any possible identification of the product.
干预措施: sterile saline (Drug)
Serratus Block
At the end of the lobectomy VATS procedure, 0,5 mL/kg of 0.375% ropivacaine will be administered.
Under ultrasonography assistance, block will be performed at the fifth rib in the midaxillary line. Local anesthetic will be injected either superficial to the serratus anterior muscle or deep underneath the muscle.
Anesthesiologists, and all the nurses and caring staff involved in this study will be blinded. Solutions of ropivacaine will be prepared identically by the central pharmacy, without any possible identification of the product.
干预措施: Ropivacaine (Drug)
结局指标
主要结局
Total intravenous morphine consumption (mg) in the PACU and department.
时间窗: 24 hours
Including the dose of titration while the patient is in PACU and PCA up to 24h postoperatively.
次要结局
未报告次要终点