Impact of Auricular Neurostimulation in Patients Undergoing Colorectal Surgery with an Enhanced Recovery Protocol: A Pilot Randomized, Controlled Trial. Dis Colon Rectum 2021 Feb 01;64(2):225-233
Date
01/09/2021Pubmed ID
33417346DOI
10.1097/DCR.0000000000001752Scopus ID
2-s2.0-85099721640 (requires institutional sign-in at Scopus site) 4 CitationsAbstract
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 narcóticos son la piedra angular del control del dolor postoperatorio, pero la epidemia de opioides y los efectos fisiológicos y psicológicos negativos de los narcóticos incentivan a los médicos a que utilicen métodos no farmacológicos de control del dolor.OBJETIVO:Este estudio piloto investigó un nuevo dispositivo de neuroestimulación para analgesia postoperatoria. Hipotetizamos que la neuroestimulación activa disminuiría los requerimientos narcóticos postoperatorios.DISEÑO:Este fue un ensayo doble ciego controlado con placebo.ESCENARIO:Esto se llevó a cabo en un centro médico académico y en un hospital de Asuntos de Veteranos (Veterans Affairs hospital).PACIENTES:Este ensayo incluyó pacientes adultos que se sometieron a resección 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 aplicó al oído derecho antes de la cirugía y se mantuvo durante 5 días.PRINCIPALES MEDIDAS DE RESULTADO:El resultado primario fue el consumo total de opioides; los resultados secundarios incluyeron dolor, náusea, ansiedad, retorno de la función intestinal, complicaciones, reingresos a 30 días y consumo de opioides a 2 semanas y a 30 días.RESULTADOS:Participaron un total de 57 pacientes y 5 se retiraron; Se incluyeron 52 pacientes en el análisis. Veintiocho pacientes recibieron un dispositivo activo y 24 recibieron un dispositivo inactivo. No hubo diferencias en el consumo total de narcóticos
Author List
Blank JJ, Liu Y, Yin Z, Spofford CM, Ridolfi TJ, Ludwig KA, Otterson MF, Peterson CYAuthors
Jacqueline Blank MD Assistant Professor in the Surgery department at Medical College of WisconsinKirk A. Ludwig MD Chief, Professor in the Surgery department at Medical College of Wisconsin
Mary F. Otterson MD Professor in the Surgery department at Medical College of Wisconsin
Carrie Peterson MD, MS, FACS, FASCRS Associate Professor in the Surgery department at Medical College of Wisconsin
Timothy J. Ridolfi MD, MS, FACS Associate Professor in the Surgery department at Medical College of Wisconsin
MESH terms used to index this publication - Major topics in bold
AdultAged
Aged, 80 and over
Analgesics, Opioid
Colectomy
Combined Modality Therapy
Double-Blind Method
Ear Auricle
Electric Stimulation Therapy
Female
Humans
Male
Middle Aged
Pain, Postoperative
Pilot Projects
Prospective Studies
Treatment Outcome
