NL-OMON52222已完成不适用
Optimal postoperative Pain management After Lung surgery (OPtriAL): multi-centre randomised trial - OPtriA
Maxima Medisch Centrum0 个研究点目标入组 420 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 420
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Patients referred for anatomical lung resection (pneumonectomy, (bi)lobectomy
- •or segmentectomy) with the intention of performing it by VATS or RATS are
- •eligible for the trial. Adult patients older than 18 years who are able to give
- •informed consent and fill out questionnaires in Dutch.
排除标准
- •Patients with contra-indications for TEA or PVB (infection at skin site,
- •increased intracranial pressure, non-correctable coagulopathy, 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. If, prior to the procedure, catheter placement during TEA is
- •unsuccessful, a continuous PVB will be given during the procedure, and, if
- •catheter placement during PVB is unsuccessful, a single shot multilevel ICNB
- •will be used. Non-inferiority will be analysed based on intention-to-treat, as
- •well as per-protocol analysis.
- •In case the lung surgeon estimates the operation to be performed through a
- •thoracotomy technique instead of a VATS the patient will be excluded.
研究者
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