经皮外周神经刺激（神经调节）治疗术后疼痛：一项随机、假对照的初步研究。
Percutaneous Peripheral Nerve Stimulation (Neuromodulation) for Postoperative Pain: A Randomized, Sham-controlled Pilot Study.
出版信息
Anesthesiology. 2021 Jul 1;135(1):95-110. doi: 10.1097/ALN.0000000000003776.
BACKGROUND
Percutaneous peripheral nerve stimulation is an analgesic technique involving the percutaneous implantation of a lead followed by the delivery of electric current using an external pulse generator. Percutaneous peripheral nerve stimulation has been used extensively for chronic pain, but only uncontrolled series have been published for acute postoperative pain. The current multicenter study was undertaken to (1) determine the feasibility and optimize the protocol for a subsequent clinical trial and (2) estimate the treatment effect of percutaneous peripheral nerve stimulation on postoperative pain and opioid consumption.
METHODS
Preoperatively, an electrical lead was percutaneously implanted to target the sciatic nerve for major foot/ankle surgery (e.g., hallux valgus correction), the femoral nerve for anterior cruciate ligament reconstruction, or the brachial plexus for rotator cuff repair, followed by a single injection of long-acting local anesthetic along the same nerve/plexus. Postoperatively, participants were randomized to 14 days of either electrical stimulation (n = 32) or sham stimulation (n = 34) using an external pulse generator in a double-masked fashion. The dual primary treatment effect outcome measures were (1) cumulative opioid consumption (in oral morphine equivalents) and (2) mean values of the "average" daily pain scores measured on the 0 to 10 Numeric Rating Scale within the first 7 postoperative days.
RESULTS
During the first 7 postoperative days, opioid consumption in participants given active stimulation was a median (interquartile range) of 5 mg (0 to 30) versus 48 mg (25 to 90) in patients given sham treatment (ratio of geometric means, 0.20 [97.5% CI, 0.07 to 0.57]; P < 0.001). During this same period, the average pain intensity in patients given active stimulation was a mean ± SD of 1.1 ± 1.1 versus 3.1 ± 1.7 in those given sham (difference, -1.8 [97.5% CI, -2.6 to -0.9]; P < 0.001).
CONCLUSIONS
Percutaneous peripheral nerve stimulation reduced pain scores and opioid requirements free of systemic side effects during at least the initial week after ambulatory orthopedic surgery.
背景
经皮外周神经刺激是一种镇痛技术，包括经皮植入导线，然后使用外部脉冲发生器输送电流。经皮外周神经刺激已广泛用于慢性疼痛，但仅发表了未经对照的用于急性术后疼痛的系列研究。本多中心研究旨在：(1)确定随后临床试验的可行性并优化方案；(2)评估经皮外周神经刺激对术后疼痛和阿片类药物消耗的治疗效果。
方法
术前，将电导线经皮植入以靶向大脚部/踝关节手术（例如，拇外翻矫正）的坐骨神经、前交叉韧带重建的股神经或肩袖修复的臂丛神经，并沿同一神经/丛单次注射长效局部麻醉剂。术后，参与者以双盲方式随机接受 14 天的电刺激（n = 32）或假刺激（n = 34），使用外部脉冲发生器。双重主要治疗效果测量指标为：(1) 累积阿片类药物消耗（以口服吗啡当量计）；(2) 术后第 1 至 7 天内，0 至 10 数字评分量表上的“平均”每日疼痛评分的平均值。
结果
在术后第 1 至 7 天期间，接受主动刺激的参与者的阿片类药物消耗中位数（四分位距）为 5 毫克（0 至 30），而接受假刺激的患者为 48 毫克（25 至 90）（几何均数比，0.20 [97.5%CI，0.07 至 0.57]；P < 0.001）。在同一时期，接受主动刺激的患者的平均疼痛强度为 1.1 ± 1.1，而接受假刺激的患者为 3.1 ± 1.7（差值，-1.8 [97.5%CI，-2.6 至-0.9]；P < 0.001）。
结论
在至少术后第 1 周的门诊骨科手术后，经皮外周神经刺激降低了疼痛评分和阿片类药物需求，且无全身副作用。
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