Auriculo-Nerve Stimulation on Post-Operative Opioid Requirement

NCT ID: NCT05506878

Last Updated: 2026-01-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 286 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-24
• Study Completion Date: 2026-09-30

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

NSS-2 BRIDGE device

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.

Group Type: ACTIVE_COMPARATOR

NSS-2 BRIDGE

Intervention Type: 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.

Placebo Bridge

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.

Group Type: SHAM_COMPARATOR

Sham NSS-2 BRIDGE

Intervention Type: 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.

Interventions

NSS-2 BRIDGE

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.

Intervention Type: DEVICE

Sham NSS-2 BRIDGE

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.

Intervention Type: DEVICE

Other Intervention Names

Bridge; Placebo

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Masimo Corporation

INDUSTRY

Sponsor Role: collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Jacques E. Chelly

OTHER

Sponsor Role: lead

Responsible Party

Jacques E. Chelly

Professor of Anesthesiology and Perioperative Medicine and Orthopedic Surgery Director, Regional Anesthesiology Fellowship Program

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jacques E Chelly, MD, PhD, MBA

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

University of Pittsburgh Medical Center - Magee-Womens Hospital

Pittsburgh, Pennsylvania, United States

Site Status: RECRUITING

UPMC Montefiore Hospital

Pittsburgh, Pennsylvania, United States

Site Status: RECRUITING

University of Pittsburgh Medical Center - Shadyside Hospital

Pittsburgh, Pennsylvania, United States

Site Status: RECRUITING

University of Pittsburgh Medical Center - Passavant Hospital

Pittsburgh, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Amy Monroe, MPH, MBA

Role: CONTACT

monroeal@upmc.edu

412-623-6382

Carly Riedmann, MPH

Role: CONTACT

riedmannca@upmc.edu

412-623-4147

Facility Contacts

Grace K Lim, MD, MS

Role: primary

limgk2@upmc.edu

Amy Monroe, MPH, MBA

Role: primary

monroeal@upmc.edu

412-623-6382

Carly Riedmann, MPH

Role: backup

riedmannca@upmc.edu

412-623-4147

Jacques E Chelly, MD, PhD, MBA

Role: primary

chelje@anes.upmc.edu

412-623-6904

Charles Lin, MD

Role: primary

linc4@upmc.edu

Other Identifiers

1R01DA054513-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY21100077

Identifier Type: -

Identifier Source: org_study_id