Ilfeld Brian M, Said Engy T, Alexander Brenton S, Ball Scott T, Abdullah Baharin, Jensen Evan J, Schaar Adam, Finneran John J
Anesthesiology, University of California San Diego, San Diego, USA.
Anesthesiology, Outcomes Research Consortium, Houston, USA.
Cureus. 2025 Feb 12;17(2):e78920. doi: 10.7759/cureus.78920. eCollection 2025 Feb.
Objectives Percutaneous auricular neuromodulation involves implanting electrodes around the ear and administering an electric current. A device is currently available in the United States, cleared to treat symptoms from opioid withdrawal, with multiple reports suggesting a possible postoperative analgesic effect. This randomized, controlled pilot study aimed to (1) assess the feasibility of a postoperative auricular neuromodulation protocol and (2) provide an estimate of its treatment effects on postoperative pain and opioid consumption following total hip arthroplasty. Methods Adults undergoing unilateral, primary, total hip arthroplasty received an auricular neuromodulation device (NSS-2 Bridge, Masimo, Irvine, California) applied following surgery. Participants were randomized to five days of either electrical stimulation or sham in a double-masked fashion and discharged home with their devices . Participants or their caretakers removed the devices at home. Results One participant randomized to active treatment removed the device the morning of postoperative day one and withdrew from the study prior to any data collection. The remaining 29 participants were included in the analysis. For the first primary outcome measure, the median (IQR) pain level in the first five days for those receiving active stimulation (n=14) was 2.5 (1.0, 3.8) versus 3.0 (1.9, 4.0) for the sham group (n=15) (P=0.721). Concurrently, the median oxycodone use for the active stimulation group was 3.5 mg (0.1, 9.5) compared to 9.0 mg (2.0, 15.3) for the sham group (P=0.263). No statistically significant differences between treatments were identified for any of the secondary outcome measures. The protocol was successful regarding participant recruitment, intervention administration, data collection, outcomes assessment, and analysis. Six participants (three from each treatment group) removed their device prior to postoperative day five due to either difficulty sleeping while using the device or pain at one of the electrode sites. Conclusions While this randomized, controlled pilot study demonstrated the feasibility of using percutaneous auricular nerve stimulation following total hip arthroplasty for both the inpatient and outpatient portions of the postoperative period, it failed to identify improvements in analgesia, opioid-sparing, or pain interference in psychological and physical functioning. Therefore, it remains unclear whether a definitive clinical trial is warranted to investigate its use following total hip arthroplasty. Further research is advisable, possibly with a different auricular neuromodulation device and larger sample sizes.
目的 经皮耳神经调节术包括在耳部周围植入电极并施加电流。目前美国有一种设备已获批用于治疗阿片类药物戒断症状，有多项报告表明其可能具有术后镇痛效果。这项随机对照试验性研究旨在：（1）评估术后耳神经调节方案的可行性；（2）估计其对全髋关节置换术后疼痛及阿片类药物使用量的治疗效果。方法 接受单侧初次全髋关节置换术的成年人在术后接受耳神经调节设备（NSS - 2 Bridge，Masimo公司，加利福尼亚州欧文市）。参与者以双盲方式随机分为接受五天电刺激或假刺激两组，并带着设备出院回家。参与者或其护理人员在家中取下设备。结果 一名随机分配至积极治疗组的参与者在术后第一天早上取下设备，并在任何数据收集前退出研究。其余29名参与者纳入分析。对于第一个主要结局指标，接受积极刺激的参与者（n = 14）术后前五天的疼痛水平中位数（IQR）为2.5（1.0，3.8），假刺激组（n = 15）为3.0（1.9，4.0）（P = 0.721）。同时，积极刺激组羟考酮的使用量中位数为3.5 mg（0.1，9.5），假刺激组为9.0 mg（2.0，15.3）（P = 0.263）。对于任何次要结局指标，各治疗组之间均未发现统计学上的显著差异。该方案在参与者招募、干预实施、数据收集、结局评估及分析方面均取得成功。六名参与者（每个治疗组三名）在术后第五天前因使用设备时难以入睡或电极部位疼痛而取下设备。结论 虽然这项随机对照试验性研究证明了全髋关节置换术后在住院和门诊术后阶段使用经皮耳神经刺激术的可行性，但未能发现其在镇痛、减少阿片类药物使用或心理及身体功能方面的疼痛干扰方面有改善。因此，对于全髋关节置换术后是否有必要进行确定性临床试验来研究其应用仍不明确。建议进一步开展研究，可能采用不同的耳神经调节设备并扩大样本量。
