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首页> 外文期刊>BMJ Open >Randomised controlled pilot study to investigate the effectiveness of thoracic epidural and paravertebral blockade in reducing chronic post-thoracotomy pain: TOPIC feasibility study protocol
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Randomised controlled pilot study to investigate the effectiveness of thoracic epidural and paravertebral blockade in reducing chronic post-thoracotomy pain: TOPIC feasibility study protocol

机译:随机对照试验研究以研究胸膜硬膜外和椎旁阻滞在减轻慢性开胸术后疼痛中的有效性:TOPIC可行性研究方案

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Abstract Introduction Open chest surgery (thoracotomy) is considered the most painful of surgical procedures. Forceful wound retraction, costochondral dislocation, posterior costovertebral ligament disruption, intercostal nerve trauma and wound movement during respiration combine to produce an acute, severe postoperative pain insult and persistent chronic pain many months after surgery is common. Three recent systematic reviews conclude that unilateral continuous paravertebral blockade (PVB) provides analgesia at least equivalent to thoracic epidural blockade (TEB) in the postoperative period, has a lower failure rate, and symptom relief that lasted months. Crucially, PVB may reduce the development of subsequent chronic pain by intercostal nerve protection or decreased nociceptive input. The overall aim is to determine in patients who undergo thoracotomy whether perioperative PVB results in reducing chronic post-thoracotomy pain (CPTP) compared with TEB. This pilot study will evaluate feasibility of a substantive trial. Methods and analysis TOPIC is a randomised controlled trial comparing the effectiveness of TEB and PVB in reducing CPTP. This is a pilot study to evaluate feasibility of a substantive trial and study processes in 2 adult thoracic centres, Heart of England NHS Foundation Trust (HEFT) and University Hospital of South Manchester NHS Foundation Trust (UHSM). The primary objective is to establish the number of patients randomised as a proportion of those eligible. Secondary objectives include evaluation of study processes. Analyses of feasibility and patient-reported outcomes will primarily take the form of simple descriptive statistics and where appropriate, point estimates of effects sizes and associated 95% CIs. Ethics and dissemination The study has obtained ethical approval from NHS Research Ethics Committee (REC number 14/EM/1280). Dissemination plan includes: informing patients and health professionals; engaging multidisciplinary professionals to support a proposal of a definitive trial and submission for a full HTA application dependent on the success of the study. Trial registration number ISRCTN45041624; Pre-results.
机译:摘要简介开胸手术(开胸手术)被认为是最痛苦的手术方法。强烈的伤口退缩,肋骨软骨脱位,后肋韧带后破坏,肋间神经外伤和呼吸过程中的伤口运动共同导致急性,严重的术后疼痛侮辱和术后几个月的持续性慢性疼痛。最近的三项系统评价得出结论,单侧持续性椎旁连续阻滞(PVB)在术后提供的镇痛效果至少相当于胸膜硬膜外阻滞(TEB),失败率较低,症状缓解持续了几个月。至关重要的是,PVB可能通过肋间神经保护或伤害性输入减少而减轻了后续慢性疼痛的发展。总体目标是确定接受开胸手术的患者与TEB相比,围手术期PVB是否可减轻慢性开胸术后疼痛(CPTP)。这项初步研究将评估实质性试验的可行性。方法与分析TOPIC是一项随机对照试验,比较了TEB和PVB降低CPTP的有效性。这是一项试点研究,旨在评估英格兰心脏NHS基金会信托基金(HEFT)和南曼彻斯特NHS基金会信托基金(UHSM)的两个成人胸部中心的实质性试验和研究过程的可行性。主要目标是确定随机分组的患者人数占合格患者的比例。次要目标包括评估学习过程。可行性和患者报告结果的分析将主要采用简单描述性统计的形式,并在适当情况下采用效应大小和相关95%CI的点估计。伦理与传播该研究已获得NHS研究伦理委员会的伦理批准(REC编号14 / EM / 1280)。传播计划包括:通知患者和卫生专业人员;让多学科专业人士支持最终试验的建议,并根据研究的成功提交完整的HTA申请。试用注册号ISRCTN45041624;结果。

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    《BMJ Open》 |2016年第12期|共页
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  • 中图分类 临床医学;
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