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Completed Not applicable Interventional

Auriculo-Nerve Stimulation on Post-Operative Opioid Requirement

ClinicalTrials.gov ID: NCT05506878

Public ClinicalTrials.gov record NCT05506878. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 4:57 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT05506878
Recruitment status
Completed
Study type
Interventional
Phase
Not applicable
Lead sponsor
Jacques E. Chelly
Other
Enrollment
286 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 23, 2022
Primary completion
Jan 12, 2026
Completion
Apr 12, 2026
Last update posted
Jul 23, 2026

2022 – 2026

United States locations

U.S. sites
4
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
University of Pittsburgh Medical Center - Magee-Womens Hospital Pittsburgh Pennsylvania 15213
UPMC Montefiore Hospital Pittsburgh Pennsylvania 15213
University of Pittsburgh Medical Center - Shadyside Hospital Pittsburgh Pennsylvania 15232
University of Pittsburgh Medical Center - Passavant Hospital Pittsburgh Pennsylvania 15237

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05506878, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 23, 2026 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05506878 live on ClinicalTrials.gov.

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