超声引导下经皮冷冻神经消融术治疗截肢后慢性幻肢痛：一项多中心随机对照试验
贵州医科大学 麻醉与电生理课题组
翻译：黄祥 编辑：杨荣峰 审校：曹莹
众所周知，截肢后幻肢痛的症状非常顽固，几乎没有有效的治疗方法。冷冻神经消融术通过低温可逆性消融周围神经。本文尝试验证这一假设，即单次冷冻神经消融术治疗可在4个月后减轻幻肢痛。
作者纳入了下肢截肢术后出现幻肢痛的患者。所有患者均接受了利多卡因的单次股神经阻滞和坐骨神经阻滞，随后被随机分组，分别在相同部位接受超声引导下经皮冷冻神经消融术（积极治疗）或假手术治疗。主要结局是采用数字分级评分法（[numeric rating scale, NRS]，0-10）测量从基线至4个月的幻肢痛平均疼痛程度的变化，之后为患者提供可选的交叉治疗。除了实施冷冻神经消融术的治疗医师（后续没有与患者互动）外，研究人员、受试者及其他临床工作人员均不知晓治疗分组情况。
两组术前幻肢痛评分相似，积极治疗组的中位数（四分位数范围）为5.0（4.0，6.0），假手术组为5.0（4.0，7.0）。4个月后，接受冷冻神经消融术的患者（n=71）和接受假手术的患者（n=73）的疼痛程度分别下降了0.5（-0.5，3.0）vs.0（0，3），评估差异（95%置信区间[confidence interval, CI]）为-0.1（-1.0-0.7），P=0.759。根据统计把关实施方案，作者未对次要终点做出推断或得出结论。然而，在发生方案偏离后出现了一起严重不良事件，即在患者腹股沟韧带下方诱发股神经（而非只有感觉功能的隐神经）冷冻损伤，造成股四头肌无力，并且存在导致患者跌倒和引发锁骨骨折的潜在风险。
在治疗4个月后，经皮冷冻神经消融术并未减轻下肢的慢性幻肢痛。然而，这些结果是基于作者的特定研究方案得出的。由于最佳的冷冻神经消融治疗参数（如冷冻持续时间和解剖治疗位点）位仍未知，因此仍需进行更深入的研究。
原始文献来源：Brian M. Ilfeld, Cameron R. Smith, Alparslan Turan, Edward R. Mariano, Matthew E. Miller, Rick L. Fisher, Andrea M. Trescot, Steven P. Cohen, James C. Eisenach, Daniel I. Sessler, J. David Prologo, Edward J. Mascha, Liu Liu, Rodney A. Gabriel, the PAINfRE Investigators; Ultrasound-guided Percutaneous Cryoneurolysis to Treat Chronic Postamputation Phantom Limb Pain: A Multicenter Randomized Controlled Trial. Anesthesiology 2023; 138:82–97
英文原文
Ultrasound-guided Percutaneous Cryoneurolysis to Treat Chronic Postamputation Phantom Limb Pain: A Multicenter Randomized Controlled Trial
Abstract
Background
Postamputation phantom pain is notoriously persistent with few validated treatments. Cryoneurolysis involves the application of low temperatures to reversibly ablate peripheral nerves. The authors tested the hypothesis that a single cryoneurolysis treatment would decrease phantom pain 4 months later.
Methods
The authors enrolled patients with a lower-limb amputation and established phantom pain. Each received a single-injection femoral and sciatic nerve block with lidocaine and was subsequently randomized to receive either ultrasound-guided percutaneous cryoneurolysis or sham treatment at these same locations. The primary outcome was the change in average phantom pain intensity between baseline and 4 months as measured with a numeric rating scale (0 to 10), after which an optional crossover treatment was offered. Investigators, participants, and clinical staff were masked to treatment group assignment with the exception of the treating physician performing the cryoneurolysis, who had no subsequent participant interaction.
Results
Pretreatment phantom pain scores were similar in both groups, with a median [quartiles] of 5.0 [4.0, 6.0] for active treatment and 5.0 [4.0, 7.0] for sham. After 4 months, pain intensity decreased by 0.5 [–0.5, 3.0] in patients given cryoneurolysis (n = 71) versus 0 [0, 3] in patients given sham (n = 73), with an estimated difference (95% CI) of –0.1 (–1.0 to 0.7), P = 0.759. Following their statistical gatekeeping protocol, the authors did not make inferences or draw conclusions on secondary endpoints. One serious adverse event occurred after a protocol deviation in which a femoral nerve cryolesion was induced just below the inguinal ligament—instead of the sensory-only saphenous nerve—which resulted in quadriceps weakness, and possibly a fall and clavicle fracture.
Conclusions
Percutaneous cryoneurolysis did not decrease chronic lower extremity phantom limb pain 4 months after treatment. However, these results were based upon the authors’ specific study protocol, and since the optimal cryoneurolysis treatment parameters such as freeze duration and anatomic treatment location remain unknown, further research is warranted.
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