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Principal Investigator: Jacques E. Chelly
Organization: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
Fiscal Year: 2024
Award: $524,156
Funding agency: National Institute on Drug Abuse
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.
Terms: <21+ years old><65 and older><65 or older><65 years of age and older><65 years of age or more><65 years of age or older><65+ years><65+ years old><> 65 years><Abdominal Pain><Absence of pain sensation><Absence of sensibility to pain><Acupuncture Therapy><Acupuncture procedure><Adult><Adult Human><Adverse effects><Affect><Affective Disorders><Aged 65 and Over><American><Anxiety><Blinded><COVID-19><CV-19><Cell Nucleus><Cervical><Colon and Rectal Surgery><Colorectal Surgery><Conduction Anesthesia><Controlled Clinical Trials><Coronavirus Infectious Disease 2019><Cranial Nerves><Data><Dependence><Development><Devices><Dose><Ear><Effectiveness><Elderly><Face><Feels no pain><Genetic><Goals><Guidelines><History><Hospitals><Human><Inflammatory><Knowledge><Legislation><Limbic System><Mental Depression><Mental Health><Mental Hygiene><Modern Man><Mood Disorders><Nerve><Nerve Plexus><No sensitivity to pain><Non-pharmacologic Therapy><Nonpharmacologic Intervention><Nonpharmacologic Therapy><Nonpharmacologic approach><Nonpharmacologic treatment><Nucleus><Operative Procedures><Operative Surgical Procedures><Opiates><Opioid><Outcome><Overdose><Pain><Painful><Pathway interactions><Patients><Perioperative><Pilot Projects><Placebo Control><Placebos><Play><Position><Positioning Attribute><Post-Operative><Post-operative Pain><Postoperative><Postoperative Pain><Postoperative Period><Property><Psychological Health><Questionnaires><Randomized><Recommendation><Recording of previous events><Regional Anesthesia><Research><Risk><Risk Factors><Rodent><Rodentia><Rodents Mammals><Role><Safety><Sham Treatment><Statutes and Laws><Surgical><Surgical Interventions><Surgical Oncology><Surgical Procedure><Techniques><Testing><Training><Treatment Period><Trigeminal System><Withdrawal Symptom><above age 65><acupuncture><addiction><addictive disorder><adulthood><advanced age><after age 65><age 65 and greater><age 65 and older><age 65 or older><age > 65><age of 65 years onward><aged 65 and greater><aged 65+><aged ≥65><analgesia><anxiety reduction><assess effectiveness><colon and rectum surgery><coronavirus disease 2019><coronavirus disease-19><coronavirus infectious disease-19><depression><determine effectiveness><determine efficacy><developmental><effectiveness assessment><effectiveness evaluation><efficacy analysis><efficacy assessment><efficacy determination><efficacy evaluation><efficacy examination><elderly patient><evaluate effectiveness><evaluate efficacy><examine effectiveness><examine efficacy><faces><facial><fighting><geriatric><glossopharyngeal><histories><human old age (65+)><improved><insight><licit opioid><multidisciplinary><neural><non-drug therapy><non-drug treatment><non-narcotic analgesic><non-opiate analgesic><non-opioid><non-opioid analgesic><non-opioid therapeutics><nondrug therapy><nondrug treatment><nonnarcotic analgesics><nonopiate analgesic><nonopioid><nonopioid analgesics><novel><old age><older patient><oncologic surgery><opiate consumption><opiate crisis><opiate deaths><opiate drug use><opiate intake><opiate medication><opiate mortality><opiate use><opiate use disorder><opiate withdrawal><opioid consumption><opioid crisis><opioid deaths><opioid detox><opioid detoxification><opioid drug use><opioid epidemic><opioid intake><opioid medication><opioid mortality><opioid overdose death><opioid related death><opioid sparing><opioid use><opioid use disorder><opioid withdrawal><over 65 years><overdose death><overdose fatalities><pain after surgery><pain relief><pandemic><pandemic disease><pathway><pilot study><placebo controlled><placebo controlled study><placebo group><post-surgical pain><postsurgical pain><prescribed opiate><prescribed opioid><prescription opiate><prescription opioid><prospective><psychologic><psychological><psychological symptom><public health relevance><randomisation><randomization><randomized, clinical trials><randomly assigned><relieve pain><senior citizen><sham group><sham therapy><social role><surgery><surgery pain><surgical pain><tool><treatment days><treatment duration><trigeminal><≥65 years>