强化康复计划下肝胰胆手术后持续伤口浸润或硬膜外镇痛预防疼痛（POP-UP试验）：一项随机对照试验的研究方案
Continuous wound infiltration or epidural analgesia for pain prevention after hepato-pancreato-biliary surgery within an enhanced recovery program (POP-UP trial): study protocol for a randomized controlled trial.
作者信息
Mungroop Timothy H, Veelo Denise P, Busch Olivier R, van Dieren Susan, van Gulik Thomas M, Karsten Tom M, de Castro Steve M, Godfried Marc B, Thiel Bram, Hollmann Markus W, Lirk Philipp, Besselink Marc G
机构信息
Department of Surgery, Academic Medical Center, University of Amsterdam, Meibergdreef 9, Postbus 22660, 1100, DD, Amsterdam, The Netherlands.
Department of Anesthesiology, Academic Medical Center, University of Amsterdam, Meibergdreef 9, Postbus 22660, 1100, DD, Amsterdam, The Netherlands.
出版信息
Trials. 2015 Dec 9;16:562. doi: 10.1186/s13063-015-1075-5.
BACKGROUND
Postoperative pain prevention is essential for the recovery of surgical patients. Continuous (thoracic) epidural analgesia (CEA) is routinely practiced for major abdominal surgery, but evidence is conflicting on its benefits in this setting. Potential disadvantages of epidural analgesia are a) perioperative hypotension, frequently requiring additional intravenous fluid boluses or prolonged use of vasopressors; b) relatively high failure rates, with periods of inadequate analgesia; and c) the risk of rare but serious, at times persistent, neurologic complications (hematoma and abscess). In recent years, continuous (subfascial) wound infiltration (CWI) plus patient-controlled analgesia (PCA) has been suggested as a safe and reliable alternative, which does not have the previously mentioned disadvantages, but evidence from multicenter trials targeting a specific surgical population is lacking. We hypothesize that CWI+PCA is equally as effective as CEA, without the mentioned disadvantages.
METHODS/DESIGN: POP-UP is a randomized controlled noninferiority multicenter trial, recruiting adult patients scheduled for elective hepato-pancreato-biliary surgery via laparotomy in an enhanced recovery setting. A total of 102 patients are being randomly allocated to CWI+PCA or (P)CEA. Our primary endpoint is the Overall Benefit of Analgesic Score (OBAS), a composite endpoint of pain intensity, opioid-related adverse effects and patient satisfaction, during postoperative days 1 to 5. Secondary endpoints include length of the hospital stay, number of patients with severe pain, and the use of rescue medication.
DISCUSSION
POP-UP is a pragmatic trial that will provide evidence of whether CWI+PCA is noninferior as compared to (P)CEA after elective hepato-pancreato-biliary surgery via laparotomy in an enhanced recovery setting. If this hypothesis is confirmed, this finding could contribute to more widespread implementation of this technique, especially when the described disadvantages of epidural analgesia are less often observed with CWI+PCA.
TRIAL REGISTRATION
Netherlands Trial Register NTR4948 (registry date 2 January 2015).
背景
术后疼痛预防对于手术患者的康复至关重要。连续（胸段）硬膜外镇痛（CEA）常用于大型腹部手术，但在这种情况下其益处的证据存在矛盾。硬膜外镇痛的潜在缺点包括：a）围手术期低血压，常需额外静脉推注液体或长时间使用血管升压药；b）相对较高的失败率，存在镇痛不足的时期；c）罕见但严重且有时持续存在的神经并发症（血肿和脓肿）风险。近年来，连续（筋膜下）伤口浸润（CWI）加患者自控镇痛（PCA）被认为是一种安全可靠的替代方法，它没有上述缺点，但缺乏针对特定手术人群的多中心试验证据。我们假设CWI + PCA与CEA同样有效，且没有上述缺点。
方法/设计：POP - UP是一项随机对照非劣效性多中心试验，招募计划在强化康复环境下通过剖腹手术进行择期肝胰胆手术的成年患者。总共102名患者被随机分配至CWI + PCA组或（P）CEA组。我们的主要终点是术后第1至5天的镇痛总体益处评分（OBAS），这是一个疼痛强度、阿片类药物相关不良反应和患者满意度的综合终点。次要终点包括住院时间、重度疼痛患者数量以及急救药物的使用情况。
讨论
POP - UP是一项实用试验，将提供证据证明在强化康复环境下通过剖腹手术进行择期肝胰胆手术后，CWI + PCA与（P）CEA相比是否非劣效。如果这一假设得到证实，这一发现可能有助于该技术更广泛地应用，特别是当CWI + PCA较少出现硬膜外镇痛所描述的缺点时。
试验注册
荷兰试验注册库NTR4948（注册日期2015年1月2日）
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