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随机对照临床试验:围手术期神经阻滞和经伤口导管持续局部麻醉浸润与硬膜外镇痛在开腹肝切除术中的比较(LIVER 2 试验)。

Randomized clinical trial of perioperative nerve block and continuous local anaesthetic infiltration via wound catheter versus epidural analgesia in open liver resection (LIVER 2 trial).

机构信息

Departments of Surgery, Royal Infirmary of Edinburgh, Edinburgh, UK.

Departments of Anaesthesia, Royal Infirmary of Edinburgh, Edinburgh, UK.

出版信息

Br J Surg. 2015 Dec;102(13):1619-28. doi: 10.1002/bjs.9949. Epub 2015 Oct 8.

Abstract

BACKGROUND

Analgesia after liver surgery remains controversial. A previous randomized trial of continuous wound infiltration (CWI) versus thoracic epidural analgesia (TEA) after liver surgery (LIVER trial) showed a faster recovery time in the wound infiltration group but better early postoperative pain scores in the TEA group. High-level evidence is, however, limited and opinion remains divided. The aim was to determine whether there is a difference in functional recovery time between patients having CWI plus abdominal nerve blocks versus TEA after liver resection.

METHODS

A randomized unblinded clinical trial of patients undergoing open liver resection was commenced in December 2012, with follow-up to August 2014. Patients were randomized to receive either wound catheter and nerve block (CWI group) or TEA for 48 h after surgery. The primary outcome measure was functional recovery time. Secondary outcomes were pain scores, complication rates, inflammatory response and central venous pressure (CVP) during transection.

RESULTS

Of 50 patients randomized initially to each group, 44 received TEA and 49 CWI. Median (i.q.r.) recovery time was 6·5 (5-9·75) and 5·75 (4-7) days in the TEA and CWI groups respectively (P = 0·036). Pain scores were not significantly different between the two groups, and there were no differences in morbidity, inflammatory response or CVP during transection.

CONCLUSION

Wound infiltration is associated with a reduced time to recovery after open liver resection compared with epidural analgesia. TEA does not offer an advantage over CWI in terms of attenuation of the inflammatory response or pain scores.

REGISTRATION NUMBER

NCT01747122 ( http://www.clinicaltrials.gov).

摘要

背景

肝手术后的镇痛仍然存在争议。先前一项关于肝手术后连续切口浸润(CWI)与胸段硬膜外镇痛(TEA)的随机试验(LIVER 试验)显示,浸润组的恢复时间更快,但 TEA 组的早期术后疼痛评分更好。然而,高级别的证据有限,意见仍然存在分歧。目的是确定肝切除术后接受 CWI 加腹部神经阻滞与 TEA 的患者在功能恢复时间上是否存在差异。

方法

2012 年 12 月开始进行一项开放肝切除术患者的随机非盲临床试验,随访至 2014 年 8 月。患者随机分为接受伤口导管和神经阻滞(CWI 组)或术后 48 小时接受 TEA。主要观察指标是功能恢复时间。次要结局指标为疼痛评分、并发症发生率、炎症反应和横断期间的中心静脉压(CVP)。

结果

最初随机分配到每组的 50 例患者中,44 例接受 TEA,49 例接受 CWI。TEA 和 CWI 组的中位(IQR)恢复时间分别为 6.5(5-9.75)和 5.75(4-7)天(P = 0.036)。两组疼痛评分无显著差异,在并发症发生率、炎症反应或横断期间的 CVP 方面也无差异。

结论

与硬膜外镇痛相比,开放肝切除术后浸润可缩短恢复时间。在减轻炎症反应或疼痛评分方面,TEA 并没有优于 CWI。

登记号

NCT01747122(http://www.clinicaltrials.gov)。

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