Dewinter Geertrui, Van de Velde Marc, Fieuws Steffen, D'Hoore Andre, Rex Steffen
Department of Anaesthesiology, KU Leuven - University of Leuven, University Hospitals of Leuven, B-3000 Leuven, Belgium.
Trials. 2014 Dec 4;15:476. doi: 10.1186/1745-6215-15-476.
Despite the laparoscopic approach becoming the standard in colorectal surgery, postoperative pain management for minimally invasive surgery is still mainly based on strategies that have been established for open surgical procedures. Patient-controlled epidural and intravenous analgesia are considered standard postoperative analgesia regimens in colorectal surgery. Epidural analgesia provides excellent analgesia, but is increasingly scrutinized in laparoscopic surgery since postoperative pain after the laparoscopic approach is significantly reduced. Moreover, epidural analgesia can be associated with numerous complications. Therefore, epidural analgesia is no longer recommended for the management of postoperative pain in laparoscopic colorectal surgery. Likewise, patient-controlled intravenous analgesia is subject to significant side effects. Given these important limitations of the traditional strategies for postoperative analgesia, effective and efficient alternatives in patients undergoing laparoscopic colorectal surgery are needed. Both the transversus abdominis plane block and systemically administered lidocaine have already been reported to effectively reduce pain after laparoscopic colorectal surgery. We hypothesize that the transversus abdominis plane block is superior to perioperative intravenous lidocaine.
METHODS/DESIGN: One hundred and twenty five patients undergoing laparoscopic colorectal surgery will be included in this prospective, randomized, double-blind controlled clinical trial. Patients will be randomly allocated to three different postoperative strategies: postoperative patient-controlled intravenous analgesia with morphine (control group, n = 25), a transversus abdominis plane block with ropivacaine 0.375% at the end of surgery plus postoperative patient-controlled intravenous analgesia with morphine (TAP group, n = 50), or perioperative intravenous lidocaine plus postoperative patient-controlled intravenous analgesia with morphine (LIDO group, n = 50). As the primary outcome parameter, we will evaluate the opioid consumption during the first 24 postoperative hours. Secondary endpoints include the Numeric Rating Scale, time to return of intestinal function, time to mobilization, inflammatory response, incidence of postoperative nausea and vomiting, length of hospital stay and postoperative morbidity as assessed with the Clavien-Dindo classification.
Recognizing the importance of a multimodal approach for perioperative pain management, we aim to investigate whether a transversus abdominis plane block delivers superior pain control in comparison to perioperative intravenous lidocaine and patient-controlled intravenous analgesia with morphine alone.
EudraCT Identifier: 2014-001499-73; 31 July 2014.
尽管腹腔镜手术已成为结直肠手术的标准术式,但微创手术的术后疼痛管理仍主要基于已确立的开放手术策略。患者自控硬膜外镇痛和静脉镇痛被认为是结直肠手术术后的标准镇痛方案。硬膜外镇痛可提供出色的镇痛效果,但在腹腔镜手术中受到越来越多的审视,因为腹腔镜手术后的疼痛显著减轻。此外,硬膜外镇痛可能会引发多种并发症。因此,不再推荐硬膜外镇痛用于腹腔镜结直肠手术的术后疼痛管理。同样,患者自控静脉镇痛也存在明显的副作用。鉴于传统术后镇痛策略存在这些重要局限性,需要为接受腹腔镜结直肠手术的患者提供有效且高效的替代方案。腹横肌平面阻滞和全身应用利多卡因均已被报道可有效减轻腹腔镜结直肠手术后的疼痛。我们假设腹横肌平面阻滞优于围手术期静脉应用利多卡因。
方法/设计:125例接受腹腔镜结直肠手术的患者将纳入这项前瞻性、随机、双盲对照临床试验。患者将被随机分配至三种不同的术后策略:术后吗啡自控静脉镇痛(对照组,n = 25)、手术结束时0.375%罗哌卡因腹横肌平面阻滞加术后吗啡自控静脉镇痛(腹横肌平面阻滞组,n = 50)或围手术期静脉应用利多卡因加术后吗啡自控静脉镇痛(利多卡因组,n = 50)。作为主要结局参数,我们将评估术后24小时内的阿片类药物消耗量。次要终点包括数字评分量表、肠功能恢复时间、活动时间、炎症反应、术后恶心呕吐发生率、住院时间以及根据Clavien-Dindo分类评估的术后并发症。
认识到多模式方法在围手术期疼痛管理中的重要性,我们旨在研究腹横肌平面阻滞与围手术期静脉应用利多卡因及单纯吗啡自控静脉镇痛相比,是否能提供更优的疼痛控制。
欧洲临床试验数据库标识符:2014-001499-73;2014年7月31日。