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术前椎旁阻滞与乳腺癌手术后慢性疼痛:一项双盲随机试验。

Preoperative Paravertebral Block and Chronic Pain after Breast Cancer Surgery: A Double-blind Randomized Trial.

机构信息

Department of Anesthesiology, Institut Curie, PSL Research University, Saint-Cloud, France.

the Biometry Unit, Institut Curie, Paris Sciences & Lettres University, Paris, France.

出版信息

Anesthesiology. 2021 Dec 1;135(6):1091-1103. doi: 10.1097/ALN.0000000000003989.

DOI:10.1097/ALN.0000000000003989
PMID:34618889
Abstract

BACKGROUND

The effectiveness of paravertebral block in preventing chronic pain after breast surgery remains controversial. The primary hypothesis of this study was that paravertebral block reduces the incidence of chronic pain 3 months after breast cancer surgery.

METHODS

In this prospective, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, 380 women undergoing partial or complete mastectomy with or without lymph node dissection were randomized to receive preoperative paravertebral block with either 0.35 ml/kg 0.75% ropivacaine (paravertebral group) or saline (control group). Systemic multimodal analgesia was administered in both groups. The primary endpoint was the incidence of chronic pain with a visual analogue scale (VAS) score greater than or equal to 3 out of 10, 3 months after surgery. The secondary outcomes were acute pain, analgesic consumption, nausea and vomiting, chronic pain at 6 and 12 months, neuropathic pain, pain interference, anxiety, and depression.

RESULTS

Overall, 178 patients received ropivacaine, and 174 received saline. At 3 months, chronic pain was reported in 93 of 178 (52.2%) and 83 of 174 (47.7%) patients in the paravertebral and control groups, respectively (odds ratio, 1.20 [95% CI, 0.79 to 1.82], P = 0.394). At 6 and 12 months, chronic pain occurred in 104 of 178 (58.4%) versus 79 of 174 (45.4%) and 105 of 178 (59.0%) versus 93 of 174 (53.4%) patients in the paravertebral and control groups, respectively. Greater acute postoperative pain was observed in the control group 0 to 2 h (area under the receiver operating characteristics curve at rest, 4.3 ± 2.8 vs. 2.9 ± 2.8 VAS score units × hours, P < 0.001) and when maximal in this interval (3.8 ± 2.1 vs. 2.5 ± 2.5, P < 0.001) but not during any other interval. Postoperative morphine use was 73% less in the paravertebral group (odds ratio, 0.272 [95% CI, 0.171 to 0.429]; P < 0.001).

CONCLUSIONS

Paravertebral block did not reduce the incidence of chronic pain after breast surgery. Paravertebral block did result in less immediate postoperative pain, but there were no other significant differences in postoperative outcomes.

摘要

背景

椎旁阻滞在预防乳腺癌手术后慢性疼痛方面的有效性仍存在争议。本研究的主要假设是椎旁阻滞可降低乳腺癌手术后 3 个月慢性疼痛的发生率。

方法

在这项前瞻性、多中心、随机、双盲、平行组、安慰剂对照研究中,380 例行部分或全乳切除术(伴或不伴淋巴结清扫术)的女性患者被随机分为椎旁阻滞组(接受术前 0.35ml/kg 0.75%罗哌卡因)和对照组(接受生理盐水)。两组均给予全身多模式镇痛。主要终点为术后 3 个月时视觉模拟评分(VAS)≥3 分的慢性疼痛发生率。次要结局包括急性疼痛、镇痛药物消耗、恶心和呕吐、6 个月和 12 个月时的慢性疼痛、神经病理性疼痛、疼痛干扰、焦虑和抑郁。

结果

总体而言,178 例患者接受了罗哌卡因,174 例患者接受了生理盐水。术后 3 个月时,椎旁阻滞组和对照组分别有 93 例(52.2%)和 83 例(47.7%)患者报告慢性疼痛(比值比,1.20[95%CI,0.79 至 1.82],P=0.394)。术后 6 个月和 12 个月时,椎旁阻滞组和对照组分别有 104 例(58.4%)和 79 例(45.4%)、105 例(59.0%)和 93 例(53.4%)患者报告慢性疼痛。对照组在 0 至 2 小时(休息时接受者操作特征曲线下面积,4.3±2.8 vs. 2.9±2.8 VAS 评分单位×小时,P<0.001)和最大疼痛时(3.8±2.1 vs. 2.5±2.5,P<0.001)的急性术后疼痛更严重,但在其他任何时间段均无差异。椎旁阻滞组术后吗啡使用率降低了 73%(比值比,0.272[95%CI,0.171 至 0.429];P<0.001)。

结论

椎旁阻滞并未降低乳腺癌手术后慢性疼痛的发生率。椎旁阻滞确实导致了即刻术后疼痛减轻,但在其他术后结局方面没有显著差异。

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