Department of General, Visceral and Transplantation Surgery, Heidelberg University Hospital, Heidelberg, Germany.
The Study Centre of the German Surgical Society, Heidelberg University Hospital, Heidelberg, Germany.
JAMA Surg. 2020 Jul 1;155(7):e200794. doi: 10.1001/jamasurg.2020.0794. Epub 2020 Jul 15.
Morbidity is still high in pancreatic surgery, driven mainly by gastrointestinal complications such as pancreatic fistula. Perioperative thoracic epidural analgesia (EDA) and patient-controlled intravenous analgesia (PCIA) are frequently used for pain control after pancreatic surgery. Evidence from a post hoc analysis suggests that PCIA is associated with fewer gastrointestinal complications.
To determine whether postoperative PCIA decreases the occurrence of gastrointestinal complications after pancreatic surgery compared with EDA.
DESIGN, SETTING, AND PARTICIPANTS: In this adaptive, pragmatic, international, multicenter, superiority randomized clinical trial conducted from June 30, 2015, to October 1, 2017, 371 patients at 9 European pancreatic surgery centers who were scheduled for elective pancreatoduodenectomy were randomized to receive PCIA (n = 185) or EDA (n = 186); 248 patients (124 in each group) were analyzed. Data were analyzed from February 22 to April 25, 2019, using modified intention to treat and per protocol.
Patients in the PCIA group received general anesthesia and postoperative PCIA with intravenous opioids with the help of a patient-controlled analgesia device. In the EDA group, patients received general anesthesia and intraoperative and postoperative EDA.
The primary end point was a composite of pancreatic fistula, bile leakage, delayed gastric emptying, gastrointestinal bleeding, or postoperative ileus within 30 days after surgery. Secondary end points included 30-day mortality, other complications, postoperative pain levels, intraoperative or postoperative use of vasopressor therapy, and fluid substitution.
Among the 248 patients analyzed (147 men; mean [SD] age, 64.9 [10.7] years), the primary composite end point did not differ between the PCIA group (61 [49.2%]) and EDA group (57 [46.0%]) (odds ratio, 1.17; 95% CI, 0.71-1.95 P = .54). Neither individual components of the primary end point nor 30-day mortality, postoperative pain levels, or intraoperative and postoperative substitution of fluids differed significantly between groups. Patients receiving EDA gained more weight by postoperative day 4 than patients receiving PCIA (mean [SD], 4.6 [3.8] vs 3.4 [3.6] kg; P = .03) and received more vasopressors (46 [37.1%] vs 31 [25.0%]; P = .04). Failure of EDA occurred in 23 patients (18.5%).
This study found that the choice between PCIA and EDA for pain control after pancreatic surgery should not be based on concerns regarding gastrointestinal complications because the 2 procedures are comparable with regard to effectiveness and safety. However, EDA was associated with several shortcomings.
German Clinical Trials Register: DRKS00007784.
胰腺手术后的发病率仍然很高，主要由胰腺瘘等胃肠道并发症引起。围手术期胸硬膜外镇痛（EDA）和患者自控静脉镇痛（PCIA）常用于胰腺手术后的疼痛控制。事后分析的证据表明，PCIA 与较少的胃肠道并发症相关。
确定与 EDA 相比，术后 PCIA 是否会降低胰腺手术后胃肠道并发症的发生。
设计、环境和参与者：这是一项适应性、务实的、国际性的、多中心的、优效性随机临床试验，于 2015 年 6 月 30 日至 2017 年 10 月 1 日进行，共有 371 名在欧洲 9 个胰腺外科中心接受择期胰十二指肠切除术的患者被随机分配接受 PCIA（n = 185）或 EDA（n = 186）；对 248 名患者（每组 124 名）进行了分析。数据于 2019 年 2 月 22 日至 4 月 25 日使用修改后的意向治疗和方案进行分析。
PCIA 组患者接受全身麻醉和术后 PCIA，静脉内使用阿片类药物，借助患者自控镇痛装置。在 EDA 组中，患者接受全身麻醉和术中及术后 EDA。
主要终点是术后 30 天内发生胰瘘、胆漏、胃排空延迟、胃肠道出血或术后肠梗阻的复合结果。次要终点包括 30 天死亡率、其他并发症、术后疼痛水平、术中或术后使用血管加压药治疗以及液体替代。
在 248 名分析的患者中（147 名男性；平均[SD]年龄 64.9[10.7]岁），PCIA 组（61[49.2%]）和 EDA 组（57[46.0%]）的主要复合终点无差异（比值比，1.17；95%CI，0.71-1.95；P = 0.54）。主要终点的各个组成部分以及 30 天死亡率、术后疼痛水平或术中术后液体替代均无显著差异。接受 EDA 的患者在术后第 4 天体重增加比接受 PCIA 的患者更多（平均[SD]，4.6[3.8]kg 与 3.4[3.6]kg；P = 0.03），接受的血管加压药也更多（46[37.1%]与 31[25.0%]；P = 0.04）。23 名（18.5%）患者 EDA 失败。
本研究发现，胰腺手术后选择 PCIA 或 EDA 进行疼痛控制不应基于对胃肠道并发症的担忧，因为这两种方法在有效性和安全性方面相当。然而，EDA 存在一些缺点。
德国临床试验注册处：DRKS00007784。
