Ilfeld Brian M, Finneran John J, Gabriel Rodney A, Said Engy T, Nguyen Patrick L, Abramson Wendy B, Khatibi Bahareh, Sztain Jacklynn F, Swisher Matthew W, Jaeger Pia, Covey Dana C, Meunier Matthew J, Hentzen Eric R, Robertson Catherine M
Department of Anesthesiology, University of California San Diego, San Diego, California, USA
The Outcomes Research Consortium, Cleveland, Ohio, USA.
Reg Anesth Pain Med. 2019 Mar;44(3):310-318. doi: 10.1136/rapm-2018-100121. Epub 2019 Feb 15.
Percutaneous peripheral nerve stimulation (PNS) is an analgesic modality involving the insertion of a lead through an introducing needle followed by the delivery of electric current. This modality has been reported to treat chronic pain as well as postoperative pain following knee and foot surgery. However, it remains unknown if this analgesic technique may be used in ambulatory patients following upper extremity surgery. The purpose of this proof-of-concept study was to investigate various lead implantation locations and evaluate the feasibility of using percutaneous brachial plexus PNS to treat surgical pain following ambulatory rotator cuff repair in the immediate postoperative period.
Preoperatively, an electrical lead (SPR Therapeutics, Cleveland, Ohio) was percutaneously implanted to target the suprascapular nerve or brachial plexus roots or trunks using ultrasound guidance. Postoperatively, subjects received 5 min of either stimulation or sham in a randomized, double-masked fashion followed by a 5 min crossover period, and then continuous stimulation until lead removal postoperative days 14-28.
Leads (n=2) implanted at the suprascapular notch did not appear to provide analgesia, and subsequent leads (n=14) were inserted through the middle scalene muscle and placed to target the brachial plexus. Three subjects withdrew prior to data collection. Within the recovery room, stimulation did not decrease pain scores during the first 40 min of the remaining subjects with brachial plexus leads, regardless of which treatment subjects were randomized to initially. Seven of these 11 subjects required a single-injection interscalene nerve block for rescue analgesia prior to discharge. However, subsequent average resting and dynamic pain scores postoperative days 1-14 had a median of 1 or less on the Numeric Rating Scale, and opioid requirements averaged less than 1 tablet daily with active stimulation. Two leads dislodged during use and four fractured on withdrawal, but no infections, nerve injuries, or adverse sequelae were reported.
This proof-of-concept study demonstrates that ultrasound-guided percutaneous PNS of the brachial plexus is feasible for ambulatory shoulder surgery, and although analgesia immediately following surgery does not appear to be as potent as local anesthetic-based peripheral nerve blocks, the study suggests that this modality may provide analgesia and decrease opioid requirements in the days following rotator cuff repair. Therefore, it suggests that a subsequent, large, randomized clinical trial with an adequate control group is warranted to further investigate this therapy in the management of surgical pain in the immediate postoperative period. However, multiple technical issues remain to be resolved, such as the optimal lead location, insertion technique, and stimulating protocol, as well as preventing lead dislodgment and fracture.
NCT02898103.
经皮外周神经刺激(PNS)是一种镇痛方式,通过导入针插入导联,随后施加电流。据报道,这种方式可用于治疗慢性疼痛以及膝关节和足部手术后的疼痛。然而,对于这种镇痛技术是否可用于上肢手术后的门诊患者,目前尚不清楚。本概念验证研究的目的是探究不同的导联植入位置,并评估在门诊患者肩袖修复术后即刻使用经皮臂丛神经PNS治疗手术疼痛的可行性。
术前,在超声引导下经皮植入一根电导联(SPR Therapeutics,俄亥俄州克利夫兰),以靶向肩胛上神经或臂丛神经根或干。术后,受试者以随机、双盲的方式接受5分钟的刺激或假刺激,随后是5分钟的交叉期,然后持续刺激直至术后14 - 28天取出导联。
植入肩胛切迹处的两根导联似乎未提供镇痛效果,随后14根导联经中斜角肌插入并靶向臂丛神经。3名受试者在数据收集前退出。在恢复室中,对于其余植入臂丛神经导联的受试者,无论最初随机分配到哪种治疗,刺激在最初40分钟内均未降低疼痛评分。这11名受试者中有7名在出院前需要单次肌间沟神经阻滞进行补救镇痛。然而,术后1 - 14天随后的平均静息和动态疼痛评分在数字评分量表上中位数为1或更低,且在进行有效刺激时阿片类药物需求量平均每天少于1片。两根导联在使用过程中移位,四根在取出时断裂,但未报告感染、神经损伤或不良后遗症。
本概念验证研究表明,超声引导下经皮臂丛神经PNS用于门诊肩部手术是可行的,尽管术后即刻的镇痛效果似乎不如基于局部麻醉的外周神经阻滞有效,但该研究表明这种方式可能在肩袖修复术后数天提供镇痛并减少阿片类药物需求量。因此,这表明有必要进行后续的、大规模的、有适当对照组的随机临床试验,以进一步研究这种疗法在术后即刻手术疼痛管理中的作用。然而,仍有多个技术问题有待解决,如最佳导联位置、插入技术和刺激方案,以及防止导联移位和断裂。
NCT02898103。