用脂质体布比卡因进行腹横肌平面阻滞与连续硬膜外镇痛治疗腹部大手术后疼痛的疗效比较：一项EXPLANE的随机试验

用脂质体布比卡因进行腹横肌平面阻滞与连续硬膜外镇痛治疗腹部大手术后疼痛的疗效比较：一项EXPLANE的随机试验

贵州医科大学     麻醉与心脏电生理课题组

翻译：潘志军   编辑：张中伟  审核：曹莹

背景：比较用脂质体布比卡因进行腹横肌平面阻滞与连续硬膜外镇痛治疗腹部大手术后恢复期患者静息痛和阿片类药物消耗的影响。ERAS模式提示腹部手术中TAP阻滞优于硬膜外镇痛。然而，TAP阻滞和硬膜外镇痛的相对有效性仍然未知。

方法：在六个地点招募了做腹部大手术的患者，并按1:1的比例随机分配到胸部硬膜外镇痛或用脂质体布比卡因进行双侧/四象限TAP阻滞。静脉注射阿片类药物根据需要使用。非劣质性范围事先设定为11分疼痛数字评分表上的1分疼痛，以及术后阿片类药物用量增加25%。

结果：超过事先的无效边界后，在第三次中期分析时，按照协议停止了入组。498名患者接受了分析（255人进行了TAP阻滞，243人进行了硬膜外麻醉）。被分配到TAP阻滞的患者在休息时的疼痛评分明显不逊于给予硬膜外麻醉的患者，估计差异为0.09分（CI：-0.12，0.30；非劣质性P<0.001）。TAP患者术后最初3天的阿片类药物消耗量并不劣于硬膜外麻醉，估计的几何平均比为1.37（CI：1.05，1.79；非劣质性P=0.754）。然而，3天内的绝对差异只有21mg吗啡当量。接受硬膜外麻醉的病人比接受TAP阻滞的病人更可能出现平均动脉压<65mmHg（48% : 31%，P=0.006）。

结论：腹部大手术后最初三天静息的疼痛评分相似。与硬膜外患者相比，接受TAP阻滞的患者需要更多的阿片类药物，但低血压发生较少。临床医生应重新考虑对有低血压风险患者进行硬膜外镇痛。 

原始文献来源：Alparslan Turan, Barak Cohen, Hesham Elsharkawy,et al.Transversus abdominis plane block with liposomal bupivacaine versus continuous epidural analgesia for major abdominal surgery: The EXPLANE randomized trial [J]. (J Clin Anesth 2022 09;80 ).

英文原文   

Transversus abdominis plane block with liposomal bupivacaine versus continuous epidural analgesia for major abdominal surgery: The EXPLANE randomized trial     

Abstract

Objective: Compare transversus abdominis plane (TAP) blocks with liposomal bupivacaine were to epidural analgesia for pain at rest and opioid consumption in patients recovering from abdominal surgery.

Background: ERAS pathways suggest TAP blocks in preference to epidural analgesia for abdominal surgery. However, the relative efficacies of TAP blocks and epidural analgesia remains unknown.

Methods: Patients having major abdominal surgery were enrolled at six sites and randomly assigned 1:1 to thoracic epidural analgesia or bilateral/4-quadrant TAP blocks with liposomal bupivacaine. Intravenous opioids were used as needed. Non-inferiority margins were a priori set at 1 point on an 11-point pain numeric rating scale for pain at rest and at a 25% increase in postoperative opioid consumption.

Results: Enrollment was stopped per protocol at 3rd interim analysis after crossing an a priori futility boundary. 498 patients were analyzed (255 had TAP blocks and 243 had epidurals). Pain scores at rest in patients assigned to TAP blocks were significantly non-inferior to those given epidurals, with an estimated difference of 0.09 points (CI:−0.12, 0.30; noninferiority P<0.001). Opioid consumption during the initial 3 postoperative days in TAP patients was not non-inferior to epidurals, with an estimated ratio of geometric means of 1.37 (CI: 1.05, 1.79; non-inferiority P=0.754). However, the absolute difference was only 21 mg morphine equivalents over the 3 days. Patients with epidurals were more likely to experience mean arterial pressures <65 mmHg than those given TAP blocks: 48% versus 31%, P=0.006.

Conclusion: Pain scores at rest during the initial three days after major abdominal surgery were similar. Patients assigned to TAP blocks required more opioid then epidural patients but had less hypotension. Clinicians should reconsider epidural analgesia in patients at risk from hypotension.

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