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.

Grant Number: 5R01DA054513-04
NIH Institute/Center: NIH
Principal Investigator: Jacques Chelly