Randomized Trial to Evaluate the Analgesic Efficacy of Inter Pleural Ropivacaine Road in Post Thoracotomy Pain for Oncologic Surgery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Proportion of Patients With Major Post-operative Pain at Mobilization Following Lung Surgery by Posterolateral Thoracotomy
研究概览
简要总结
Thoracic surgery via posterolateral thoracotomy causes significant postoperative pain.
There are several methods of postoperative pain relief, including intravenous analgesics and local-regional analgesia techniques. Although thoracic epidural remains the gold standard, it is not without complications, which are rare but serious, and should be reserved for trained teams or patients with high morbidity.
Intrapleural analgesia is a simple method, performed by the surgeon intraoperatively.
Its effectiveness is controversial and the results remain inconsistent. Ropivacaine is a recently marketed local anesthetic with a modest vasoconstrictive effect. The variation in plasma levels of ropivacaine obtained by this technique has not yet been evaluated.
The purposes of this study are:
- To determine the efficacy of inter pleural analgesia
- To determine the plasmatic concentration of ropivacaine by inter pleural road
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
Individual series of products were prepared by the Pharmacy according to a list (randomization list pre-established by the biostatistics department), which was not accessible to anyone until the results were analyzed. The treatments were sent by the pharmacy to the operating room in the form of pre-filled syringes with no distinguishing marks indicating the treatment group. Blindness was maintained during the evaluation period.
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
- •Thoracotomy for oncology thoracic surgery
- •Secondary or primary cancer
- •American Society of Anesthesiology (ASA) class 1 or 2
排除标准
- •Ropivacaine hypersensibility
- •Psychiatric disorders
- •Incapacity of using visual analog scale
研究组 & 干预措施
Ropivacaine Arm
ropivacaine at 7.5 mg/ml: 4 ml + 4 ml of saline solution to obtain 8 ml of a ropivacaine solution at 3.75 mg/ml injected into the intrapleural catheter every 6 hours.
Treatment administration = every 6 hours for 48 hours.
干预措施: Ropivacaine (Drug)
Reference Arm
8 ml of saline solution will be injected into the intrapleural catheter. Treatment administration = every 6 hours for 48 hours.
干预措施: Reference (Drug)
结局指标
主要结局
Proportion of Patients With Major Post-operative Pain at Mobilization Following Lung Surgery by Posterolateral Thoracotomy
时间窗: Between surgery and up to 48 hours
Pain is measured using a visual analog scale (VAS), ranging from 0 (no pain) to 100 (worst pain ever). A participant is considered to have major pain if VAS score is \>= 70.
次要结局
- Post-operative Morphine Consumption Following Lung Surgery by Posterolateral Thoracotomy(between surgery and 48 hours)