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NCT05506878 · ClinicalTrials.gov registry record · NA
Auriculo-Nerve Stimulation on Post-Operative Opioid Requirement
A NA study of Opioid Use and Liver Transplant, sponsored by Jacques E. Chelly.
- Recruiting
- Registry status
- NA
- Development phase
- 286
- Enrollment target
- 4
- Study locations
NCT05506878: Recruiting NA study of Opioid Use and Liver Transplant, sponsored by Jacques E. Chelly.
NCT05506878 is a NA study of Opioid Use and Liver Transplant that is actively recruiting participants, run by Jacques E. Chelly. The registered enrollment target is 286 participants, below the 148,257-participant average among 105 other Opioid Use trials with a reported enrollment target (100% lower). The trial reports 4 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05506878, a NA study of Opioid Use and Liver Transplant, is actively recruiting participants, sponsored by Jacques E. Chelly.
- RECRUITING
- Registry status
- NA
- Development phase
- 286 participants
- Enrollment target
- 4
- Study locations
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.
Primary Outcome
Assess how the use of the NSS-2 BRIDGE Device over 5 days stimulation period affect the participant's total opioid consumption using morphine equivalent following an open abdominal or pelvic surgery.
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 |
What NCT05506878 shows while recruiting
NCT05506878 is an interventional study that assigns participants to a tested intervention. The registered 286 participants enrollment target is mid-sized for trials with a published cap, below the 148,257-participant average among 105 other Opioid Use trials with a reported enrollment target (100% lower).
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.
NCT05506878 reports a single indexed study location in Pennsylvania.
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.
What interventions are being tested in trial NCT05506878?
The interventions under investigation include: NSS-2 BRIDGE (DEVICE), Sham NSS-2 BRIDGE (DEVICE).
Who is sponsoring clinical trial NCT05506878?
This trial is sponsored by Jacques E. Chelly, which has 10 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT05506878's enrollment target sits among peer trials
286 29th of 105 higher than 77 of 105 other Opioid Use trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Opioid Use trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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