Optimal Postoperative Pain Management After Lung Surgery (OPtriAL): Multi-centre Randomised Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 450
- 试验地点
- 2
- 主要终点
- Pain scores
研究概览
简要总结
Adequate pain control after video-assisted thoracoscopic surgery (VATS) for lung resection is important to improve postoperative mobilisation, recovery, and to prevent pulmonary complications. So far, no consensus exists on optimal postoperative pain management after VATS anatomic lung resection.
Thoracic epidural analgesia (TEA) is the reference standard for postoperative pain management following VATS. Although the analgesic effect of TEA is clear, it is associated with patient immobilisation, bladder dysfunction and hypotension which may result in delayed recovery and longer hospitalisation. These disadvantages of TEA initiated the development of unilateral regional techniques for pain management. The most frequently used techniques are continuous paravertebral block (PVB) and single-shot intercostal nerve block (ICNB).
The investigators hypothesize that using either PVB or ICNB is non-inferior to TEA regarding postoperative pain and superior regarding quality of recovery (QoR). Signifying faster postoperative mobilisation, reduced morbidity and shorter hospitalisation, these techniques may therefore reduce health care costs and improve patient satisfaction.
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
- None
盲法说明
As the analgesic strategies highly differ in nature (with or without percutaneous catheter) and/or postoperative care (mobility with or without prerequisites, urinary catheter placement), blinding for the randomised strategy is unfeasible.
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
- •Adult patients (>18 years)
- •Patients referred for anatomic lung resection (pneumonectomy, (bi)lobectomy or segmentectomy for either benign or malignant disease) with the intention of performing it by video-assisted thoracoscopic surgery (VATS) or robot-assisted thoracoscopic surgery (RATS)
- •Patients should be able to provide informed consent and fill out questionnaires in Dutch language.
排除标准
- •Patients with contra-indications for TEA or PVB (infection at skin site, increased intracranial pressure, non-correctable coagulopathy, bridging indication for therapeutic anticoagulation (CHADS-VASc ≥ 8), sepsis and mechanical spine obstruction) or allergic reactions to local anaesthetics will be excluded.
- •Patients chronically using opioids for reasons not related to the operation will be excluded from the study since postoperative baseline opioid requirement will be higher and TEA remains the preferred technique for these patients.
- •In case the lung surgeon estimates the operation to be performed through a thoracotomy instead of VATS/RATS
结局指标
主要结局
Pain scores
时间窗: Postoperative day 0-2
Proportion of pain scores ≥4 as assessed by the numerical rating scale (NRS) (measured from 0 until 10; lowest value signifying no pain and highest value signifying worst pain)
Quality of Recovery (QoR)
时间窗: Postoperative day 1-2
QoR measured with the QoR-15 questionnaire on postoperative 1 and 2 (maximum score of 150, the higher the score the better the outcome)
次要结局
- cumulative use of opioids and analgesics(Postoperative day 0 until 3 as well as the use and dosage of opioid use at the follow-up period 2-3 weeks after the operation)
- postoperative complications(until 2-3 weeks of follow-up)
- hospitalisation(30 postoperative days)
- patient satisfaction(Postoperative day 0 until 3)
- degree of mobility(Postoperative day 0 until 3)
研究者
Louisa Spaans
Coordinating Investigator, MD
Maxima Medical Center