Auriculo-Nerve Stimulation on Post-Operative Opioid Requirement

NCT05506878 | Recruiting DMC FDA Device

• 2 other identifiers: STUDY211000771R01DA054513-01A1
• Study Type: interventional
• Target: 286
• Locations: 1 country
• Sites: 4

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.

Conditions

Opioid Use; Auriculotherapy; Liver Transplant; Pain, Abdominal; Cancer Pain

Keywords

anesthesiology; auricular neurostimulation; auriculotherapy; open surgery; opioids; pain management

Outcome Measures

Primary Outcomes (1)

• Opioid Consumption

  Assess how the use of the NSS-2 BRIDGE Device over 5 days stimulation period affect the participant's total opioid consumption using morphine equivalent following an open abdominal or pelvic surgery.

  (OME) at 24 hours, 48 hours, 72 hours, 96 hours, 120 hours post-operative

Secondary Outcomes (23)

• Post-operative pain rating using a numerical rating scale

  1 hour post NBD placement, days 1,2,3,4,5 post-operative, 1 month post-operative, 3 months post-operative

• Area under the curve of post-operative pain rating using a numerical rating scale

  1 hour post NBD placement, days 1,2,3,4,5 post-operative, 1 month post-operative, 3 months post-operative

• Post-operative nausea and vomiting rating

  1 hour post NBD placement, days 1, 2, 3, 4, & 5 post-operative

• Pre-operative emotional distress related to anxiety

  Baseline, pre-surgery

• Post-operative change in emotional distress related to anxiety

  Day 1, 2, 3, 4, 5, 1 month, and 3 months post-operative

Study Arms (2)

NSS-2 BRIDGE device

ACTIVE COMPARATOR

This experimental arm involves the use of the NSS-2 BRIDGE device, which is a disposable device that stimulates the branches of cranial nerves and of the superficial cervical plexus innervating the ear. It will be placed on the subject immediately after surgery and worn for 5 days. It is a percutaneous nerve field stimulator (PNFS) system, that can be used as an aid to reduce the symptoms of opioid withdrawal, through application to branches of Cranial Nerves V, VII, IX and X, and the occipital nerves identified by transillumination.

Device: NSS-2 BRIDGE

Placebo Bridge

SHAM COMPARATOR

The sham group involves the use of 3 non-active points, or "nonfunctional points." The sham device will be placed on the subject immediately post-operatively and worn for 5 days just like the active group.

Device: Sham NSS-2 BRIDGE

Interventions

NSS-2 BRIDGE DEVICE

NBD® will be applied to either the right or left ear in the immediate post-operative setting (PACU). Only a trained and certified research member who has completed the necessary training required by the company will place the device. The individual placing the device will not be involved in any follow up of the subject or any data collection as that researcher will be unblinded to the treatment allocation. The patient, nurses, surgeons, and other members of the research team will all remain blinded to the treatment allocation. Once the device is placed, subjects will be asked to perform a "pinch test" throughout the duration of their time wearing the device. To perform the "pinch test" subjects must pinch down on the electrodes and ground to ensure the electrodes are still placed in their designated locations and have not come loose.

Also known as: Bridge

NSS-2 BRIDGE device

Sham NSS-2 BRIDGE DEVICE

Sham NBD® will be applied to either the left or right ear in the immediate post-operative setting (PACU). Only a trained and certified research member who has completed the necessary training required by the company will place the device. The individual placing the device will not be involved in any follow up of the subject or any data collection as that researcher will be unblinded to the treatment allocation. The patient, nurses, surgeons, and other members of the research team will all remain blinded to the treatment allocation.

Also known as: Placebo

Placebo Bridge

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Over 18 years of age
• 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.
• Expected hospital stay of approximately 5 days

You may not qualify if:

• Patients who are considered by the medical or surgical team to not be able to give consent
• 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.
• 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.
• 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.
• 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.
• Surgical procedure performed laparoscopically
• Non elective surgery
• Pregnancy
• Contraindication for use of NBD® (including patients with cardiac pacemaker, hemophilia, and psoriasis vulgaris diagnosis and/or ear eczema)
• Patients intubated with sedation, and/or receiving fentanyl infusion for sedation post-surgery.
• Rapid recovery surgeries
• Subjects with a diagnosed seizure disorder
• Use of dexmedetomidine in the ICU

Sponsors & Collaborators

• Jacques E. Chelly: lead
• Masimo Corporation: collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (4)

University of Pittsburgh Medical Center - Magee-Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

UPMC Montefiore Hospital

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

University of Pittsburgh Medical Center - Shadyside Hospital

Pittsburgh, Pennsylvania, 15232, United States

RECRUITING

University of Pittsburgh Medical Center - Passavant Hospital

Pittsburgh, Pennsylvania, 15237, United States

RECRUITING

MeSH Terms

Conditions

Abdominal Pain; Cancer Pain; Agnosia

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Jacques E Chelly, MD, PhD, MBA

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amy Monroe, MPH, MBA

CONTACT

412-623-6382; monroeal@upmc.edu

Carly Riedmann, MPH

CONTACT

412-623-4147; riedmannca@upmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 3 researchers have been appointed to randomization and are not participating in any part of the study other than treatment allocation. The researcher applying the device will not know the treatment allocation, and everyone else (participant, care provider, investigator and outcomes assessor) will be blinded to treatment allocation as well.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Anesthesiology and Perioperative Medicine and Orthopedic Surgery Director, Regional Anesthesiology Fellowship Program

Model Details: Active device versus Sham Device

Study Record Dates

• First Submitted: August 11, 2022
• First Posted: August 18, 2022
• Study Start: October 24, 2022
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Every 6 months for 4 years.
• Access Criteria: The PI will be ultimately responsible for coordinating, obtaining and sharing de-identified Electronic Health Record (EHR)-based and electronically reported and prospectively collected clinical and outcome data.

Locations

US (4)