术前超声引导下经皮冷冻神经松解术治疗乳腺癌术后疼痛：一项随机、参与者和观察者双盲、假手术对照研究。

Preoperative Ultrasound-guided Percutaneous Cryoneurolysis for the Treatment of Pain after Mastectomy: A Randomized, Participant- and Observer-masked, Sham-controlled Study.

机构信息

Department of Anesthesiology, University of California San Diego, La Jolla, California; Outcomes Research, Cleveland, Ohio.

Departments of Anesthesiology, University of California San Diego, La Jolla, California; Outcomes Research, Cleveland, Ohio.

出版信息

Anesthesiology. 2022 Nov 1;137(5):529-542. doi: 10.1097/ALN.0000000000004334.

DOI:10.1097/ALN.0000000000004334

PMID:35929983

Abstract

BACKGROUND

Ultrasound-guided percutaneous cryoneurolysis is an analgesic technique in which a percutaneous probe is used to reversibly ablate a peripheral nerve(s) using exceptionally low temperature, and has yet to be evaluated with randomized, controlled trials. Pain after mastectomy can be difficult to treat, and the authors hypothesized that the severity of surgically related pain would be lower on postoperative day 2 with the addition of cryoanalgesia compared with patients receiving solely standard-of-care treatment.

METHODS

Preoperatively, participants at one enrolling center received a single injection of ropivacaine, 0.5%, paravertebral nerve block at T3 or T4, and perineural catheter. Participants subsequently underwent an active or sham ultrasound-guided percutaneous cryoneurolysis procedure of the ipsilateral T2 to T5 intercostal nerves in a randomized, patient- and observer-masked fashion. Participants all received a continuous paravertebral block with ropivacaine, 0.2%, until the early morning of discharge (usually postoperative day 2). The primary endpoint was the average pain level measured using a 0 to 10 numeric rating scale the afternoon of postoperative day 2. Participants were followed for 1 yr.

RESULTS

On postoperative day 2, participants who had received active cryoneurolysis (n = 31) had a median [interquartile range] pain score of 0 [0 to 1.4] versus 3.0 [2.0 to 5.0] in patients given sham (n = 29): difference -2.5 (97.5% CI, -3.5 to -1.5), P < 0.001. There was evidence of superior analgesia through month 12. During the first 3 weeks, cryoneurolysis lowered cumulative opioid use by 98%, with the active group using 1.5 [0 to 14] mg of oxycodone compared with 72 [20 to 120] mg in the sham group (P < 0.001). No oral analgesics were required by any patient between months 1 and 12. After 1 yr chronic pain had developed in 1 (3%) active compared with 5 (17%) sham participants (P < 0.001).

CONCLUSIONS

Percutaneous cryoneurolysis markedly improved analgesia without systemic side effects or complications after mastectomy.

摘要

背景

超声引导下经皮冷冻神经松解术是一种镇痛技术，通过使用极低的温度可逆地消融外周神经，尚未通过随机对照试验进行评估。乳腺癌手术后的疼痛可能难以治疗，作者假设与接受单纯标准治疗的患者相比，添加冷冻镇痛后，术后第 2 天手术相关疼痛的严重程度会降低。

方法

在一个入组中心，术前参与者接受单次椎旁神经阻滞注射 0.5%罗哌卡因 T3 或 T4 及外周神经导管。参与者随后以随机、患者和观察者盲法的方式接受同侧 T2 至 T5 肋间神经的超声引导下经皮冷冻神经松解术或假手术。所有参与者均接受连续椎旁阻滞，用 0.2%罗哌卡因至出院（通常在术后第 2 天清晨）。主要终点是术后第 2 天下午使用 0 到 10 的数字评分量表测量的平均疼痛水平。参与者随访 1 年。

结果

术后第 2 天，接受冷冻神经松解术的参与者（n=31）的中位数[四分位距]疼痛评分为 0[0 至 1.4]，而接受假手术的参与者（n=29）的疼痛评分为 3.0[2.0 至 5.0]：差值-2.5（97.5%置信区间，-3.5 至-1.5），P<0.001。在第 12 个月时仍有更好的镇痛效果。在前 3 周，冷冻神经松解术使累积阿片类药物用量降低了 98%，接受冷冻神经松解术的患者使用了 1.5[0 至 14]mg 羟考酮，而接受假手术的患者使用了 72[20 至 120]mg（P<0.001）。在第 1 至 12 个月期间，没有任何患者需要口服镇痛药。1 年后，1 例（3%）接受冷冻神经松解术的患者出现慢性疼痛，而 5 例（17%）接受假手术的患者出现慢性疼痛（P<0.001）。