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Paravertebral catheter versus EPidural analgesia in Minimally invasive Esophageal resectioN: a randomized controlled multicenter trial (PEPMEN trial).

椎旁导管与硬膜外镇痛在微创食管切除术中的比较: 一项随机对照多中心试验 (PEPMEN 试验)。

  • 影响因子:3.29
  • DOI:10.1186/s12885-020-6585-1
  • 作者列表:"Kingma BF","Eshuis WJ","de Groot EM","Feenstra ML","Ruurda JP","Gisbertz SS","Ten Hoope W","Marsman M","Hermanides J","Hollmann MW","Kalkman CJ","Luyer MDP","Nieuwenhuijzen GAP","Scholten HJ","Buise M","van Det MJ","Kouwenhoven EA","van der Meer F","Frederix GWJ","Cheong E","Al Naimi K","van Berge Henegouwen MI","van Hillegersberg R
  • 发表时间:2020-02-22
Abstract

BACKGROUND:Thoracic epidural analgesia is the standard postoperative pain management strategy in esophageal cancer surgery. However, paravertebral block analgesia may achieve comparable pain control while inducing less side effects, which may be beneficial for postoperative recovery. This study primarily aims to compare the postoperative quality of recovery between paravertebral catheter versus thoracic epidural analgesia in patients undergoing minimally invasive esophagectomy. METHODS:This study represents a randomized controlled superiority trial. A total of 192 patients will be randomized in 4 Dutch high-volume centers for esophageal cancer surgery. Patients are eligible for inclusion if they are at least 18 years old, able to provide written informed consent and complete questionnaires in Dutch, scheduled to undergo minimally invasive esophagectomy with two-field lymphadenectomy and an intrathoracic anastomosis, and have no contra-indications to either epidural or paravertebral analgesia. The primary outcome is the quality of postoperative recovery, as measured by the Quality of Recovery-40 (QoR-40) questionnaire on the morning of postoperative day 3. Secondary outcomes include the QoR-40 questionnaire score Area Under the Curve on postoperative days 1-3, the integrated pain and systemic opioid score and patient satisfaction and pain experience according to the International Pain Outcomes (IPO) questionnaire, and cost-effectiveness. Furthermore, the groups will be compared regarding the need for additional rescue medication on postoperative days 0-3, technical failure of the pain treatment, duration of anesthesia, duration of surgery, total postoperative fluid administration day 0-3, postoperative vasopressor and inotrope use, length of urinary catheter use, length of hospital stay, postoperative complications, chronic pain at six months after surgery, and other adverse effects. DISCUSSION:In this study, it is hypothesized that paravertebral analgesia achieves comparable pain control while causing less side-effects such as hypotension when compared to epidural analgesia, leading to shorter postoperative length of stay on a monitored ward and superior quality of recovery. If this hypothesis is confirmed, the results of this study can be used to update the relevant guidelines on postoperative pain management for patients undergoing minimally invasive esophagectomy. TRIAL REGISTRATION:Netherlands Trial Registry, NL8037. Registered 19 September 2019.

摘要

背景: 胸段硬膜外镇痛是食管癌术后的标准疼痛管理策略。然而,椎旁阻滞镇痛可能达到相当的疼痛控制,同时诱导较少的副作用,这可能有利于术后恢复。本研究主要旨在比较微创食管切除术患者椎旁导管与胸段硬膜外镇痛的术后恢复质量。 方法: 本研究代表了一项随机对照优势试验。共有 192 名患者将被随机分配到 4 个荷兰高容量中心进行食管癌手术。如果患者至少 18 岁,能够提供书面知情同意书并完成荷兰语问卷, 计划行微创食管切除术,行二野淋巴结清扫术和胸内吻合,对硬膜外或椎旁镇痛均无禁忌。主要结果是术后恢复质量,通过术后第 3 天上午的恢复质量-40 (QoR-40) 问卷进行测量。次要结局包括术后第 1-3 天的 QoR-40 问卷评分曲线下面积,根据国际疼痛结局 (IPO) 问卷的综合疼痛和全身阿片评分以及患者满意度和疼痛体验,以及成本效益。此外,将比较各组在术后 0-3 天需要额外的抢救药物、疼痛治疗的技术失败、麻醉持续时间、手术持续时间, 术后总液体给药 0-3 天,术后血管加压药和肌注使用,尿管使用时间,住院时间,术后并发症、术后 6 个月的慢性疼痛和其他不良反应。 讨论: 在本研究中,假设椎旁镇痛与硬膜外镇痛相比,可实现相当的疼痛控制,同时引起较少的副作用,如低血压, 导致在监测病房的术后住院时间缩短,恢复质量优越。如果这一假设得到证实,本研究结果可用于更新微创食管切除术患者术后疼痛管理的相关指南。 试验注册: 荷兰试验登记处,nl8037。2019年9月19日注册。

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