Supplementary Epidural Analgesia in Video-Assisted Thoracic Surgery (VATS) - The SEAVATS Study

Odense University Hospital1 个研究点分布在 1 个国家目标入组 161 人开始时间: 2015年2月最近更新: 2023年6月27日

适应症

干预措施

试验速览

阶段: 4 期
状态: 已完成
发起方: Odense University Hospital
入组人数: 161
试验地点: 1
主要终点: Intensity of pain (Self reported pain intensity)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Whereas it, in the case of conventional thoracotomy, has been demonstrated that thoracic epidural analgesia is more effective than systemic opioids in terms of pain relief and preservation of postoperative pulmonary function, the efficacy of epidural analgesia in video-assisted thoracic surgical (VATS) procedures, has not been sufficiently studied, but a beneficial effect might very well be present.

On the other hand, the risks associated with placement of a thoracic epidural catheter are well known and if similar pain relief can be achieved without it with no or only insignificant alternative side effects, this would be preferable.

The literature regarding the usefulness of epidural analgesia for reducing pain in Video-Assisted Thoracic Surgery is, at best, scarce with two small studies showing some effect and two showing no difference, none of the studies being blinded randomized controlled trials of adequate size.

The SEAVATS Study will try to answer this question.

详细描述

Study plan:

The hypothesis is that there is no difference in the amount of pain the patients will experience after VATS for pulmonary neoplasms.

Study design and setting:

The project is designed as a prospectively, double blinded, randomized, placebo controlled study comparing pain in two groups of patients.

Both groups of patients will:

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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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

•Planned elective VATS lobectomy, wedge- or segmental resection. (for the subsequent biomarker study, only lobectomy is a inclusion criteria, specified in protocol amendment July 27th 2016)
•Patient has accepted to have epidural analgesia as part of the anaesthesia for the procedure.
•Informed consent is attained.
•Patient is over 18 years of age.
•Patient is mentally able to answer questionnaires included in the study.

排除标准

•Allergies to any of the medications used in the trial.
•History of previous peptic ulcer.
•History of chronic pain to any degree that will interfere with quantification of pain postoperatively.
•Dementia or reduced mental capacity to any degree that will interfere with quantification of pain postoperatively.
•Pregnancy.
•Contra-indications to placement of epidural catheter.
•Any concurrent cancer disease or use of immune modulating drugs (criteria added as part of a protocol amendment July 27th 2016 for a subsequent biomarkers study)