Pak Linda Ma, Haroutounian Simon, Hawkins William G, Worley Lori, Kurtz Monika, Frey Karen, Karanikolas Menelaos, Swarm Robert A, Bottros Michael M
Department of Surgery, Washington University in Saint Louis School of Medicine, St. Louis, Missouri, USA.
Department of Anesthesiology, Division of Pain Management, Washington University School of Medicine, St. Louis, Missouri, USA.
BMJ Open. 2018 Jan 26;8(1):e018787. doi: 10.1136/bmjopen-2017-018787.
Epidural analgesia provides an important synergistic method of pain control. In addition to reducing perioperative opioid consumption, the deliverance of analgesia into the epidural space, effectively creating a sympathetic blockade, has a multitude of additional potential benefits, from decreasing the incidence of postoperative delirium to reducing the development of persistent postsurgical pain (PPSP). Prior studies have also identified a correlation between the use of epidural analgesia and improved oncological outcomes and survival. The aim of this study is to evaluate the effect of epidural analgesia in pancreatic operations on immediate postoperative outcomes, the development of PPSP and oncological outcomes in a prospective, single-blind, randomised controlled trial.
The Epidurals in Pancreatic Resection Outcomes (E-PRO) study is a prospective, single-centre, randomised controlled trial. 150 patients undergoing either pancreaticoduodenectomy or distal pancreatectomy will be randomised to receive an epidural bupivacaine infusion following anaesthetic induction followed by continued epidural bupivacaine infusion postoperatively in addition to the institutional standardised pain regimen of hydromorphone patient-controlled analgesia (PCA), acetaminophen and ketorolac (intervention group) or no epidural infusion and only the standardised postoperative pain regimen (control group). The primary outcome was the postoperative opioid consumption, measured in morphine or morphine-equivalents. Secondary outcomes include patient-reported postoperative pain numerical rating scores, trend and relative ratios of serum inflammatory markers (interleukin (IL)-1β, IL-6, tumour necrosis factor-α, IL-10), occurrence of postoperative delirium, development of PPSP as determined by quantitative sensory testing, and disease-free and overall survival.
The E-PRO trial has been approved by the institutional review board. Recruitment began in May 2016 and will continue until the end of May 2018. Dissemination plans include presentations at scientific conferences and scientific publications.
NCT02681796.
硬膜外镇痛是一种重要的协同性疼痛控制方法。除了减少围手术期阿片类药物的使用外，将镇痛药物注入硬膜外间隙，有效地形成交感神经阻滞，还有许多其他潜在益处，从降低术后谵妄的发生率到减少持续性术后疼痛（PPSP）的发生。先前的研究还发现硬膜外镇痛的使用与改善肿瘤学结局和生存率之间存在关联。本研究的目的是在前瞻性、单盲、随机对照试验中评估硬膜外镇痛在胰腺手术中对术后即刻结局、PPSP的发生以及肿瘤学结局的影响。
胰腺切除术后硬膜外镇痛效果（E-PRO）研究是一项前瞻性、单中心、随机对照试验。150例行胰十二指肠切除术或胰体尾切除术的患者将被随机分组，在麻醉诱导后接受硬膜外布比卡因输注，并在术后继续输注硬膜外布比卡因，同时采用机构标准化的氢吗啡酮患者自控镇痛（PCA）、对乙酰氨基酚和酮咯酸疼痛方案（干预组），或不进行硬膜外输注，仅采用标准化的术后疼痛方案（对照组）。主要结局是术后阿片类药物的使用量，以吗啡或吗啡等效物衡量。次要结局包括患者报告的术后疼痛数字评分、血清炎症标志物（白细胞介素（IL）-1β、IL-6、肿瘤坏死因子-α、IL-10）的趋势和相对比值、术后谵妄的发生情况、通过定量感觉测试确定的PPSP的发生情况以及无病生存期和总生存期。
E-PRO试验已获得机构审查委员会的批准。招募工作于2016年5月开始，将持续至2018年5月底。传播计划包括在科学会议上发表演讲和发表科学论文。
NCT02681796。
