RecruitingNot ApplicableNCT05506878

Auriculo-Nerve Stimulation on Post-Operative Opioid Requirement

Reduction of Opioid Requirement Associated With Auriculo-Nerve Stimulation Following Open Surgery


Sponsor

Jacques E. Chelly

Enrollment

286 participants

Start Date

Oct 24, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a small device placed in the ear to stimulate a nerve (called auricular nerve stimulation) can reduce the amount of opioid pain medication patients need after abdominal or pelvic cancer surgery. The goal is to help manage post-surgery pain more safely with less reliance on opioids. **You may be eligible if...** - You are 18 years or older - You are scheduled for open abdominal or pelvic surgery to remove colorectal cancer, or a liver resection at specific UPMC hospitals - You are following the standard recovery protocol (ERAS) for that surgery - You are willing to have the small ear device placed during or after surgery **You may NOT be eligible if...** - You have an active infection in the ear - You have a pacemaker or other implanted electronic device that could interfere - You are currently dependent on opioids before surgery - You have had a prior allergic reaction to the materials in the device - You are unable to give consent or follow study procedures Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICENSS-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.

DEVICESham 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.


Locations(4)

University of Pittsburgh Medical Center - Magee-Womens Hospital

Pittsburgh, Pennsylvania, United States

UPMC Montefiore Hospital

Pittsburgh, Pennsylvania, United States

University of Pittsburgh Medical Center - Shadyside Hospital

Pittsburgh, Pennsylvania, United States

University of Pittsburgh Medical Center - Passavant Hospital

Pittsburgh, Pennsylvania, United States

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NCT05506878


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