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Auriculo-Nerve Stimulation on Post-Operative Opioid Requirement
NCT05506878 · View on ClinicalTrials.gov ↗
Study 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 Studied
Interventions
- DEVICE NSS-2 BRIDGE
- DEVICE Sham NSS-2 BRIDGE
Study Locations (4)
Pennsylvania
- University of Pittsburgh Medical Center - Magee-Womens Hospital — Pittsburgh
- UPMC Montefiore Hospital — Pittsburgh
- University of Pittsburgh Medical Center - Shadyside Hospital — Pittsburgh
- University of Pittsburgh Medical Center - Passavant Hospital — Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 286 participants |
| Start Date | 2022-10-24 |
| Est. Completion | 2026-09-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05506878
The ClinicalTrials.gov registry entry for NCT05506878 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 286 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Jacques E. Chelly, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 5 conditions, with Opioid Use appearing as the primary indexed condition, and to 2 interventions — of which NSS-2 BRIDGE is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05506878 reports 4 study locations spanning 1 distinct geographic area — top geographies include Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05506878 about?
NCT05506878 is a clinical study titled "Auriculo-Nerve Stimulation on Post-Operative Opioid Requirement". 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 m...
What is the current status of trial NCT05506878?
This trial is currently recruiting. It is a NA study. The enrollment target is 286 participants. The study started on 2022-10-24. Estimated completion is 2026-09-30.
What conditions does trial NCT05506878 study?
This clinical trial studies the following conditions: Opioid Use, Liver Transplant, Cancer Pain, Auriculotherapy, Pain, Abdominal. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05506878?
The interventions under investigation include: NSS-2 BRIDGE (DEVICE), Sham NSS-2 BRIDGE (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05506878?
This trial is sponsored by Jacques E. Chelly, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05506878 being conducted?
This trial has 4 study locations across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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