Chelly Jacques E, Holtzman Matthew P, Bartlett David L, Choudry Haroon A, Pingpank James F, Zureikat Amer H, Norton Brittany E, Sadhasivam Senthilkumar K, Vogt Keith M
Department of Anesthesiology and Perioperative Medicine, University of Pittsburgh and UPMC (University of Pittsburgh Medical Center), Pittsburgh, PA.
Department of Surgery, Division of Surgical Oncology, University of Pittsburgh and UPMC, Pittsburgh, PA.
J Pain Manag Ther Care. 2024;3(2). doi: 10.36266/jpmtc/119. Epub 2024 May 8.
Determine the effect on opioid use after surgery with use of the NSS-2 Bridge device (NBD) as a field nerve stimulator of the nerves innervating the ear for 5 days.
This was a prospective, randomized, double-blind, placebo-controlled trial investigating the effectiveness of the NBD in reducing opioid (expressed as oral morphine equivalent; OME, mg) requirement in subjects undergoing abdominal surgery for cancer. A total of 53 subjects randomly assigned to receive either an active NBD (NBD group) or placebo NBD (placebo group) were included in the analysis. Secondary endpoints included pain using a verbal analogue scale (VAS, 0 = no pain to 10 = worst possible pain), time to ambulation, oral intake, first bowel movement, discharge from the hospital, and tolerability of the NBD. Lastly, functional recovery rated using the 12-item Short Form Survey (SF12) assessed at three months.
Use of the NBD resulted in a 26% overall reduction in OME with no difference in pain level expressed as the area under the curve between postoperative day 1 to 5. respectively). This overall reduction accounts for a 6% reduction in OME in the patients undergoing laparoscopic surgery and a 39% reduction in OME and 25% reduction in pain in patients undergoing open surgery. The tolerability of the device was reported as excellent.
Cancer patients have been identified as a population at risk of developing opioid use disorders. This prospective, randomized, double-blind, placebo-controlled study, demonstrated that NBD may be an effective alternative to the use of opioid postoperatively in patients undergoing abdominal surgery for cancer, especially in especially in patients undergoing open surgery and in elderly.
使用NSS-2桥接装置(NBD)作为支配耳部神经的场神经刺激器,持续5天,确定其对术后阿片类药物使用的影响。
这是一项前瞻性、随机、双盲、安慰剂对照试验,旨在研究NBD在降低癌症腹部手术患者阿片类药物(以口服吗啡当量表示;OME,毫克)需求量方面的有效性。共有53名随机分配接受活性NBD(NBD组)或安慰剂NBD(安慰剂组)的受试者纳入分析。次要终点包括使用视觉模拟量表(VAS,0 = 无疼痛至10 = 可能的最严重疼痛)评估的疼痛、下床活动时间、口服摄入量、首次排便、出院情况以及NBD的耐受性。最后,在三个月时使用12项简短形式调查问卷(SF12)评估功能恢复情况。
使用NBD导致OME总体降低26%,术后第1天至第5天曲线下面积所表示的疼痛水平无差异。这种总体降低在腹腔镜手术患者中导致OME降低6%,在开放手术患者中导致OME降低39%,疼痛降低25%。据报告该装置的耐受性极佳。
癌症患者已被确定为有发生阿片类药物使用障碍风险的人群。这项前瞻性、随机、双盲、安慰剂对照研究表明,NBD可能是癌症腹部手术患者术后使用阿片类药物的有效替代方法,尤其是在开放手术患者和老年患者中。