Impact of Auricular Neurostimulation in Patients Undergoing Colorectal Surgery with an Enhanced Recovery Protocol: A Pilot Randomized, Controlled Trial.

Background Narcotics are the cornerstone of postoperative pain control, but the opioid epidemic and the negative physiological and psychological effects of narcotics implore physicians to utilize nonpharmacological methods of pain control. Objective This pilot study investigated a novel neurostimulation device for postoperative analgesia. We hypothesized that active neurostimulation would decrease postoperative narcotic requirements. Design This was a placebo-controlled, double-blinded trial. Settings This trial was conducted at an academic medical center and a Veterans Affairs hospital. Patients This trial included adult patients who underwent elective bowel resection between December 2016 and April 2018. Interventions Patients were randomly assigned to receive an active or inactive (sham) device, which was applied to the right ear before surgery and continued for 5 days. Main outcome measures The primary outcome was total opioid consumption. The secondary outcomes included pain, nausea, anxiety, return of bowel function, complications, 30-day readmissions, and opioid consumption at 2 weeks and 30 days. Results A total of 57 patients participated and 5 withdrew; 52 patients were included in the analysis. Twenty-eight patients received an active device and 24 received an inactive device. There was no difference in total narcotic consumption between active and inactive devices (90.79 ± 54.93 vs 90.30 ± 43.03 oral morphine equivalents/day). Subgroup analyses demonstrated a benefit for patients after open surgery (p = 0.0278). When patients were stratified by decade, those aged 60 to 70 and >70 years derived a benefit from active devices in comparison with those aged 30 to 40, 40 to 50, and 50 to 60 years old (p = 0.01092). No serious adverse events were related to this study. Limitations This study was limited by the small sample sizes. Conclusions No difference in opioid use was found with auricular neurostimulation. However, this pilot study suggests that older patients and those with larger abdominal incisions may benefit from auricular neurostimulation. Further investigation in these high-risk patients is warranted. See Video Abstract at http://links.lww.com/DCR/B452.ClinicalTrials.gov identifier: NCT02892513. Impacto de la neuroestimulacin auricular en pacientes sometidos a ciruga colorrectal con un protocolo de recuperacin mejorada un ensayo piloto aleatorizado y controlado ANTECEDENTES:Los narcoticos son la piedra angular del control del dolor postoperatorio, pero la epidemia de opioides y los efectos fisiologicos y psicologicos negativos de los narcoticos incentivan a los medicos a que utilicen metodos no farmacologicos de control del dolor.OBJETIVO:Este estudio piloto investigo un nuevo dispositivo de neuroestimulacion para analgesia postoperatoria. Hipotetizamos que la neuroestimulacion activa disminuiria los requerimientos narcoticos postoperatorios.DISENO:Este fue un ensayo doble ciego controlado con placebo.ESCENARIO:Esto se llevo a cabo en un centro medico academico y en un hospital de Asuntos de Veteranos (Veterans Affairs hospital).PACIENTES:Este ensayo incluyo pacientes adultos que se sometieron a reseccion intestinal electiva entre diciembre de 2016 y abril de 2018.INTERVENCIONES:Los pacientes fueron asignados al azar para recibir un dispositivo activo o inactivo (falso), que se aplico al oido derecho antes de la cirugia y se mantuvo durante 5 dias.PRINCIPALES MEDIDAS DE RESULTADO:El resultado primario fue el consumo total de opioides; los resultados secundarios incluyeron dolor, nausea, ansiedad, retorno de la funcion intestinal, complicaciones, reingresos a 30 dias y consumo de opioides a 2 semanas y a 30 dias.RESULTADOS:Participaron un total de 57 pacientes y 5 se retiraron; Se incluyeron 52 pacientes en el analisis. Veintiocho pacientes recibieron un dispositivo activo y 24 recibieron un dispositivo inactivo. No hubo diferencias en el consumo total de narcoticos entre los dispositivos activos e inactivos (90.79 ± 54.93 vs 90.30 ± 43.03 equivalentes de morfina oral [OME] / dia). Los analisis de subgrupos demostraron un beneficio para los pacientes despues de cirugia abierta (p = 0.0278). Cuando los pacientes se estratificaron por decada, aquellos de 60-70 y > 70 anos obtuvieron un beneficio de los dispositivos activos en comparacion con los de 30-40, 40-50 y 50-60 anos (p = 0.01092). No hubo eventos adversos graves relacionados con este estudio.LIMITACIONES:Este estudio estuvo limitado por los pequenos tamanos de muestra.CONCLUSIONES:No se encontro diferencia en el uso de opioides con la neuroestimulacion auricular. Sin embargo, este estudio piloto sugiere que los pacientes mayores y aquellos con incisiones abdominales mas grandes pueden beneficiarse de la neuroestimulacion auricular. Esta justificada la investigacion adicional en estos pacientes de alto riesgo. Consulte Video Resumen en http://links.lww.com/DCR/B452. (Traduccion-Dr. Jorge Silva Velazco).