Reduction of opioid requirement associated with Auriculo-nerve stimulation following open surgery

PROJECT SUMMARY: Perioperative prescription of opioids is an important contributor to the current opioid epidemic, affecting ~4% of >50 million Americans undergoing surgery each year. The dose and duration of treatment of opioid in surgical patients is an established risk factor of opioid use disorder and overdose deaths.

Although legislation and guidelines have been developed to limit the quantity of opioids prescribed following surgery in the US, in 2020, the number of opioid overdose deaths increased by 39% with worsening mental health and opioid use disorder in the context of COVID-19. Developing alternative and effective surgical

analgesia and techniques to avoid or minimize the perioperative opioid use and opioid use disorder are critical in the fight of the current opioid epidemic. Auriculotherapy, a form of acupuncture, is an effective opioid-sparing alternative to treat pain. Use of traditional auriculotherapy is limited because the long and specific training

requirement. Recently, a novel battery-powered and disposable auriculo-nerve field stimulator, NSS-2 Bridge Device® (NBD®), has been developed to overcome the limitations of the traditional auriculotherapy. NBD® is a disposable device that stimulates the branches of cranial nerves and of the superficial cervical plexus innervating

the ear. The device has been cleared by the FDA to treat opioid withdrawal symptoms which includes abdominal pain and anxiety. The NBD® requires minimal training and allow to stimulate the auricular nerves for 5 days making NBD® a potential groundbreaking non-pharmacological approach to limit opioid use and prescription.

Rodent studies are supportive of the NBD modulating pain pathways and decreasing inflammatory abdominal pain. Our human surgical pain pilot data is supportive that NBD® was effective in reducing postoperative opioid requirement in adults undergoing open surgery, especially in vulnerable older patients (>65-years). Our central

hypothesis is that compared to a placebo, the NBD® will be an effective opioid-sparing tool in patients undergoing open surgery, and that the effectiveness of the NBD would be greater in vulnerable geriatric patients (age >65-years). Since, anxiety, depression, and catastrophizing increase post-operative pain and opioid

requirement by up to 50% and since auriculotherapy reduces psychological symptoms, we also hypothesized that using NBD® will also reduce anxiety, depression and catastrophizing and that represents a mechanism by which NBD® reduce perioperative opioid requirements. Our multidisciplinary team is well positioned to test the

following specific aims: 1) Quantify the opioid sparing property of NBD® following open surgery in vulnerable geriatric patients in a randomized, blinded, placebo-controlled clinical trial, 2) Evaluate the efficacy of NBD® in reducing postoperative depression, anxiety and catastrophization, and 3) Determine the effects of NBD® on the

relationship of the postoperative psychological scores and opioid consumption. This research is expected to improve surgical pain relief, safety of postoperative opioids while minimizing opioid use, dependence, and risk of OUD in millions of Americans who have painful surgeries each year.