罗哌卡因在乳腺癌手术中创面和肋间间隙浸润的双盲随机试验

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A Double-blind Randomized Trial of Wound and Intercostal Space Infiltration with Ropivacaine during Breast Cancer Surgery

  摘 要  

1

背景与目的

3

结果

2

方法

4

结论

背景与目的：伤口处行局部浸润麻醉治疗急性和慢性术后疼痛的效果存在争议，目前还没有详细的研究。本研究的主要目的是评估罗哌卡因伤口浸润对乳房手术后慢性疼痛的影响。

1

方法：在这个前瞻性的，随机的，双盲的，平行对照的研究中，236个被安排进行乳腺癌手术的病人被随机分配（1:1）接受罗哌卡因或安慰剂渗透伤口，第二和第三肋间隙。在麻醉恢复室每30分钟评估急性疼痛，镇痛剂消耗，恶心和呕吐直到2小时，后每6小时评估一次直到48小时。术后3个月，6个月和1年通过简易疼痛量表，抑郁情绪测定表以及神经病理性疼痛问卷对慢性疼痛进行评估。

结果：罗哌卡因局部浸润显着降低了术后90分钟的急性疼痛，但在术后3个月、6个月和12个月时并未降低慢性疼痛。 在3个月时，罗哌卡因组和安慰剂组慢性疼痛的发生率分别为33％和27％（P = 0.37）。在随访期间，两组患者的疼痛、焦虑随时间增加而增强（P <0.001），而抑郁症则保持稳定。 其余无并发症发生。

结论：这项多中心的前瞻性研究表明，术后3,6和12个月时，乳腺癌手术后罗哌卡因伤口处局部浸润能够减少术后急性疼痛，但并未降低慢性疼痛。

    原始文献来源   

Albi-Feldzer A, Mouret-Fourme E E, Hamouda S, et al. 

A double-blind randomized trial of wound and intercostal space infiltration with ropivacaine during breast cancer surgery: effects on chronic postoperative pain[J].

 Anesthesiology, 2013, 118(2):318-326.

BACKGROUND:The efficacy of local anesthetic wound infiltration for the treatment of acute and chronic postoperative pain is controversial and there are no detailed studies. The primary objective of this study was to evaluate the influence of ropivacaine wound infiltration on chronic pain after breast surgery.

METHODS: In this prospective, randomized, double-blind, parallel-group, placebo-controlled study, 236 patients scheduled for breast cancer surgery were randomized (1:1) to receive ropivacaine or placebo infiltration of the wound,the second and third intercostal spaces and the humeral insertion of major pectoralis. Acute pain, analgesic consumption, nausea and vomiting were assessed every 30 min for 2 h in the postanesthesia care unit and every 6 h for 48 h. Chronic pain was evaluated 3 months, 6 months, and 1 yr after surgery by the brief pain inventory hospital anxiety and depression, and neuropathic pain questionnaires.

RESULTS:Ropivacaine wound infiltration significantly decreased immediate postoperative pain for the first 90 min, but did not decrease chronic pain at 3 months (primary endpoint), or at 6 and 12 months postoperatively. At 3 months,the incidence of chronic pain was 33% and 27% (P = 0.37) in the ropivacaine and placebo groups, respectively. During follow-up, brief pain inventory, neuropathic pain, and anxiety increased over time in both groups (P < 0.001) while depression remained stable. No complications occurred.

CONCLUSIONS:This multicenter, prospective study shows that ropivacaine wound infiltration after breast cancer surgery decreased immediate postoperative pain but did not decrease chronic pain at 3, 6, and 12 months postoperatively.

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