Clinical trial NCT05506878: Auriculo-Nerve Stimulation on Post-Operative Opioid Requirement
Official title: Reduction of Opioid Requirement Associated With Auriculo-Nerve Stimulation Following Open Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Opioid Use
Auriculotherapy
Pain, Abdominal
Cancer Pain
Liver Transplant
Keywords: anesthesiology
auricular neurostimulation
auriculotherapy
open surgery
opioids
pain management
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Masimo Corporation
name: National Institute on Drug Abuse (NIDA)
First posted: 2022-08-18
Enrollment: 286
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Active device versus Sham Device
Primary purpose: TREATMENT

Brief summary: The NSS-2 BRIDGE® device (NSS stands for Neuro-Stimulation System) is a disposable device that stimulates the branches of cranial nerves and of the superficial cervical plexus innervating the ear. Because the stimulation of the nerves of the ear by the NSS-2 BRIDGE® device (NBD®) has been shown to modulate pain pathways in rodents, decrease abdominal pain in adolescents with inflammatory bile syndrome and due to the results of our preliminary pilot study, the investigators hypothesized that this technique may also be effective in reducing the requirement for postoperative opioids and provide a non-pharmacological alternative to perioperative opioid use.

To establish the role that the stimulation of the nerves of the ear may have in reducing postoperative opioid requirement, the investigators are proposing to conduct a randomized, placebo controlled study in patients undergoing open abdominal or pelvic surgery requiring at least 5 days of hospitalization. Subjects who have signed an informed consent will be randomized in 2 groups (active NBD® group or inactive NBD® group).

Furthermore, since preoperative and postoperative mood disorders have been shown to increase postoperative pain levels and opioid requirement by up to 50%, the investigators further hypothesize that the stimulation of the ear nerves by the NSS-2 BRIDGE® effects may be in part mediated by a reduction of the level of anxiety, depression and catastrophizing as assessed using validated questionnaires.

Detailed description: It is established that the perioperative prescription of opioids, including doses prescribed after discharge from the hospitals, is an important contributor to the current opioid epidemic. Although many factors have been implicated including history of addiction, mood disorders and the type of surgery, the quantity and duration of opioid treatment play an important role in a patient's development of opioid use disorder (OUD). Despite recommendations by the majority of surgery and anesthesiology professionals to limit the perioperative use of opioids, and to favor the use of non-opioid analgesics, OUD remains a serious concern. Consequently, developing alternative techniques to minimize the perioperative use of opioids is critical in the fight against the current opioid epidemic.

Auriculotherapy, a form of acupuncture is an ancient technique used to treat many conditions, including pain. Its mechanism of action is believed to be primarily via the stimulation of the branches of the vagal, trigeminal, glossopharyngeal, hypogastric, facial and superficial cervical plexus nerves innervating which secondarily modulate the pain pathway and the limbic system at the level of the brainstem, spin and central nervous system. However, the use of auriculotherapy has been limited in part by the requirement for long and specific training and the lack of well-designed clinical trials demonstrating its effectiveness.

This study design is based on the high frequency of OUD following surgery for cancer and the positive results from our exploratory Institutional Review Board (IRB)- approved, randomized and placebo-controlled pilot study that assessed the effects of the NSS-2 BRIDGE® device on perioperative pain and opioid requirement in different surgical oncology models. This was a study that included subjects undergoing both open and laparoscopic procedures of different types of surgeries for abdominal cancer.

Eligibility criteria: Inclusion Criteria:

1. Over 18 years of age
2. Scheduled for elective open primary abdominal and pelvic colorectal cancer resection surgical procedures at UPMC Shadyside Hospital, UPMC Magee-Women's Hospital, or UPMC Passavant Hospital and following the standard ERAS protocol. OR scheduled for a living-donor liver transplant surgery at UPMC Montefiore Hospital under the ERAS protocol.
3. Expected hospital stay of approximately 5 days

Exclusion Criteria:

1. Patients who are considered by the medical or surgical team to not be able to give consent
2. Clinical evidence of anxiety, depression, including suicidal ideation. The diagnostic will be based on medical history, the current treatment, and the clinical examination. The PI or Co-I will be the one making the determination to enroll the subject after the subject undergoes psychosocial testing included in the protocol and that corresponding scores have been established. These tests will only be conducted after the patient has signed an informed consent form.
3. Chronic pain condition that at the discretion of the PI, should exclude the subject from participating -or- chronic opioid use defined as daily use of 60 mg of oral opioid equivalent. The diagnostic will be based on the medical history, the current treatment, and the clinical examination. The PI or Co-I will be the one making the determination to enroll the subject.
4. True allergy to all opioid medications. The diagnostic will be based on the medical history, and the determination of the symptoms associated with the recorded allergy. The PI or Co-I will be the one making the determination to enroll the subject.
5. History of or current alcohol abuse (defined as daily use of more than 1 liter of wine and/or 3 or more shots of hard liquor) or drug abuse (defined as daily use of illicit drugs) for at least 3 months. The PI or Co-I will be the one making the determination to enroll the subject.
6. Surgical procedure performed laparoscopically
7. Non elective surgery
8. Pregnancy
9. Contraindication for use of NBD® (including patients with cardiac pacemaker, hemophilia, and psoriasis vulgaris diagnosis and/or ear eczema)
10. Patients intubated with sedation, and/or receiving fentanyl infusion for sedation post-surgery.
11. Rapid recovery surgeries
12. Subjects with a diagnosed seizure disorder
13. Use of dexmedetomidine in the ICU

Primary outcomes:
measure: Opioid Consumption
timeFrame: (OME) at 24 hours, 48 hours, 72 hours, 96 hours, 120 hours post-operative
Secondary outcomes:
measure: Post-operative pain rating using a numerical rating scale
timeFrame: 1 hour post NBD placement, days 1,2,3,4,5 post-operative, 1 month post-operative, 3 months post-operative
measure: Area under the curve of post-operative pain rating using a numerical rating scale
timeFrame: 1 hour post NBD placement, days 1,2,3,4,5 post-operative, 1 month post-operative, 3 months post-operative
measure: Post-operative nausea and vomiting rating
timeFrame: 1 hour post NBD placement, days 1, 2, 3, 4, & 5 post-operative
measure: Pre-operative emotional distress related to anxiety
timeFrame: Baseline, pre-surgery
measure: Post-operative change in emotional distress related to anxiety
timeFrame: Day 1, 2, 3, 4, 5, 1 month, and 3 months post-operative
measure: Pre-operative emotional distress related to depression
timeFrame: Baseline, pre-surgery
measure: Post-operative change in emotional distress related to depression
timeFrame: Day 1, 2, 3, 4, 5, 1 month, and 3 months post-operative
measure: Pre-operative sleep disturbance
timeFrame: Baseline, pre-surgery
measure: Post-operative change in sleep disturbance
timeFrame: Day 1, 2, 3, 4, 5, 1 month, and 3 months post-operative
measure: Pre-operative pain rating using the Pain Catastrophizing Scale
timeFrame: Baseline, pre-surgery
measure: Change in post-operative pain rating using the Pain Catastrophizing Scale
timeFrame: Day 1, 2, 3, 4, 5, 1 month, and 3 months post-operative
measure: Pre-operative Brief Symptom Index Somatization Scale
timeFrame: Baseline, pre-surgery
measure: Change in the Brief Symptom Index Somatization Scale
timeFrame: Day 1, 2, 3, 4, 5, 1 month, and 3 months post-operative
measure: Time to Oral Intake
timeFrame: Day of surgery up to 5 days
measure: Time to Ambulation
timeFrame: Day of surgery up to 5 days
measure: Time to discharge from the recovery unit
timeFrame: Day of surgery up to 5 days
measure: Length of hospital stay
timeFrame: Day of surgery up to 30 days
measure: Device tolerability
timeFrame: Time of device placement, 1 hour after placement, 6, 12, 18, 24, 48, 72, 96, and 120 hours post-operative
measure: Overall Patient Satisfaction
timeFrame: Day of Surgery through discharge or post-operative day 30, whichever comes first
measure: Total Opioid Consumption
timeFrame: Post-operative day 5, 1-month, and 3-months post-operative
measure: Prescription Drug Monitoring Program (PDMP)
timeFrame: Post-operative day 30
measure: Prescription Drug Monitoring Program (PDMP)
timeFrame: Post-operative day 60
measure: Prescription Drug Monitoring Program (PDMP)
timeFrame: Post-operative day 90
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center - Magee-Womens Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Montefiore Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center - Shadyside Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center - Passavant Hospital
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Jacques E Chelly, MD, PhD, MBA
role: PRINCIPAL_INVESTIGATOR
References: