Auriculo-Nerve Stimulation on Post-Operative Opioid Requirement

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
• Pain, Abdominal
• Cancer Pain
• Liver Transplant

Interventions

DEVICE

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.

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.

Sponsors & Collaborators

• Masimo Corporation

  collaborator INDUSTRY

• National Institute on Drug Abuse (NIDA)

  collaborator NIH

• Jacques E. Chelly

  lead OTHER

Principal Investigators

• Jacques E Chelly, MD, PhD, MBA · University of Pittsburgh

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-10-24

Primary Completion

2026-06-30

Completion

2026-09-30

FDA Device

Yes

Countries

• United States

Study Locations