Paterson Hugh, Vadiveloo Thenmalar, Innes Karen, Balfour Angie, Atter Marek, Stoddart Andrew, Cotton Seonaidh, Arnott Robert, Aucott Lorna, Batham Zoe, Foo Irwin, MacLennan Graeme, Nimmo Susan, Speake Doug, Norrie John
University of Edinburgh, Edinburgh, United Kingdom.
Western General Hospital, Edinburgh, United Kingdom.
JAMA. 2025 Jan 7;333(1):39-48. doi: 10.1001/jama.2024.23898.
Despite the recovery advantages of minimally invasive surgical techniques, delayed return of gut function after colectomy is a common barrier to timely discharge from hospital.
To evaluate the effect of 2% perioperative intravenous lidocaine infusion on return of gut function after elective minimally invasive colon resection.
DESIGN, SETTING, AND PARTICIPANTS: The ALLEGRO trial was a randomized, placebo-controlled, double-blind trial conducted in 27 UK hospitals. A total of 590 adults scheduled for elective minimally invasive colon resection for benign or malignant disease were randomized 1:1 to 2% intravenous lidocaine or saline placebo. Enrollment occurred from August 13, 2018, to April 11, 2023, with a pause in recruitment from March 20, 2020, through July 6, 2020; final follow-up was on August 10, 2023.
The intervention patients received 2% intravenous lidocaine administered as 1.5-mg/kg bolus at induction of anesthesia followed by 1.5 mg/kg/h for 6 or 12 hours. Control patients received 0.9% saline placebo for 6 or 12 hours.
The primary outcome was the proportion of patients with return of gut function at 72 hours after surgery, defined by the GI-3 composite end point of tolerating diet (ingestion of food and drink without significant nausea or vomiting for 3 consecutive meals) and passage of flatus or stool. There were 11 secondary outcomes, including time to GI-3 recovery, time to GI-2 recovery (tolerance of oral diet and passage of stool), prolonged postoperative ileus, postoperative nausea and vomiting score, Overall Benefit of Analgesia Score, postoperative opioid consumption, Quality of Recovery-15, quality of life (EuroQol 5-Dimension 5-Level), enhanced recovery protocol adherence, time to meeting medically defined criteria for discharge, and time to patient self-assessed readiness for discharge.
The trial enrolled 590 patients (295 intervention, 295 control); after 33 postrandomization exclusions, 557 patients were included (279 intervention, 278 control; 249 female patients [44.7%]; mean [SD] age, 66 [10.9] years); 532 (96%) received the randomized treatment. Return of gut function as defined by the GI-3 composite outcome was achieved at 72 hours by 160 patients (57.3%) in the intravenous lidocaine group vs 164 patients (59.0%) in the placebo group (adjusted absolute difference, -1.9% [95% CI, -8.0% to 4.2%]; relative risk, 0.97 [95% CI, 0.88 to 1.07]). There was no significant difference between the intervention and control groups in any of the 11 secondary end points.
Among patients undergoing elective minimally invasive colon resection, perioperative administration of 2% intravenous lidocaine did not improve return of gut function at 72 hours.
isrctn.org Identifier: ISRCTN52352431.
尽管微创外科技术具有恢复优势，但结肠切除术后肠道功能延迟恢复是及时出院的常见障碍。
评估围手术期静脉输注2%利多卡因对择期微创结肠切除术后肠道功能恢复的影响。
设计、地点和参与者：ALLEGRO试验是一项在27家英国医院进行的随机、安慰剂对照、双盲试验。共有590名计划因良性或恶性疾病接受择期微创结肠切除术的成年人按1:1随机分为2%静脉利多卡因组或生理盐水安慰剂组。入组时间为2018年8月13日至2023年4月11日，2020年3月20日至2020年7月6日暂停招募；最终随访时间为2023年8月10日。
干预组患者在麻醉诱导时静脉注射2%利多卡因，剂量为1.5mg/kg推注，随后以1.5mg/kg/h的速度持续输注6或12小时。对照组患者接受0.9%生理盐水安慰剂输注6或12小时。
主要结局是术后72小时肠道功能恢复的患者比例，由胃肠道-3复合终点定义，即耐受饮食（连续3餐摄入食物和饮料且无明显恶心或呕吐）以及排气或排便。有11个次要结局，包括胃肠道-3恢复时间、胃肠道-2恢复时间（耐受口服饮食和排便）、术后肠梗阻延长、术后恶心呕吐评分、镇痛总体获益评分、术后阿片类药物消耗量、恢复质量-问卷15项版本、生活质量（欧洲五维度健康量表）、强化康复方案依从性、达到医学定义出院标准的时间以及患者自我评估的出院准备时间。
该试验共纳入590例患者（295例干预组，295例对照组）；随机分组后排除33例患者，最终纳入557例患者（279例干预组，278例对照组；249例女性患者[44.7%]；平均[标准差]年龄为66[10.9]岁）；532例（96%）接受了随机分配的治疗。静脉利多卡因组160例患者（57.3%）在72小时时达到胃肠道-3复合结局定义的肠道功能恢复，安慰剂组为164例患者（59.0%）（校正绝对差异为-1.9%[95%置信区间，-8.0%至4.2%]；相对风险为0.97[95%置信区间，0.88至1.07]）。干预组和对照组在11个次要终点中的任何一项上均无显著差异。
在接受择期微创结肠切除术的患者中，围手术期静脉输注2%利多卡因并未改善术后72小时的肠道功能恢复情况。
isrctn.org标识符：ISRCTN52352431
