Anesthesiology, University of California San Diego, La Jolla, California, USA
Outcomes Research, Cleveland Clinic, Cleveland, Ohio, USA.
Reg Anesth Pain Med. 2024 Sep 2;49(9):628-634. doi: 10.1136/rapm-2024-105283.
Percutaneous auricular nerve stimulation (neuromodulation) involves implanting electrodes around the ear and administering an electric current. A device is currently available within the USA cleared to treat symptoms from opioid withdrawal, and multiple reports suggest a possible postoperative analgesic effect. The current randomized controlled pilot study was undertaken to (1) determine the feasibility and optimize the protocol for a subsequent definitive clinical trial; and (2) estimate the treatment effect of auricular neuromodulation on postoperative pain and opioid consumption following two ambulatory surgical procedures.
Within the recovery room following cholecystectomy or hernia repair, an auricular neuromodulation device (NSS-2 Bridge, Masimo, Irvine, California, USA) was applied. Participants were randomized to 5 days of either electrical stimulation or sham in a double-blinded fashion.
In the first 5 days, the median (IQR) pain level for active stimulation (n=15) was 0.6 (0.3-2.4) vs 2.6 (1.1-3.7) for the sham group (n=15) (p=0.041). Concurrently, the median oxycodone use for the active stimulation group was 0 mg (0-1), compared with 0 mg (0-3) for the sham group (p=0.524). Regarding the highest pain level experienced over the entire 8-day study period, only one participant (7%) who received active stimulation experienced severe pain, versus seven (47%) in those given sham (p=0.031).
Percutaneous auricular neuromodulation reduced pain scores but not opioid requirements during the initial week after cholecystectomy and hernia repair. Given the ease of application as well as a lack of systemic side effects and reported complications, a definitive clinical trial appears warranted.
NCT05521516.
经皮耳神经刺激（神经调节）涉及在耳朵周围植入电极并施加电流。目前美国有一种设备已获准用于治疗阿片类药物戒断症状，并有多项报告表明其可能具有术后镇痛作用。本研究旨在：(1)确定随后进行的确定性临床试验的可行性并优化方案；(2)评估耳神经调节对两种门诊手术术后疼痛和阿片类药物消耗的治疗效果。
在胆囊切除术或疝修补术后的恢复室中，应用耳神经调节装置（NSS-2 Bridge，Masimo，加利福尼亚州欧文）。参与者以双盲方式随机分为电刺激组或假刺激组，共 5 天。
在最初的 5 天内，活跃刺激组（n=15）的中位数（IQR）疼痛水平为 0.6（0.3-2.4），而假刺激组（n=15）为 2.6（1.1-3.7）（p=0.041）。同时，活跃刺激组的羟考酮使用中位数为 0 毫克（0-1），而假刺激组为 0 毫克（0-3）（p=0.524）。关于整个 8 天研究期间经历的最高疼痛水平，仅 1 名（7%）接受活跃刺激的参与者经历了严重疼痛，而接受假刺激的 7 名（47%）参与者经历了严重疼痛（p=0.031）。
经皮耳神经刺激可降低胆囊切除术和疝修补术后最初一周的疼痛评分，但不能降低阿片类药物的需求。鉴于其易于应用以及缺乏全身副作用和报告的并发症，似乎有必要进行确定性临床试验。
NCT05521516。
