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NCT03834142 · ClinicalTrials.gov registry record · NA

NSS-2-BRIDGE Study for Total Knee and Hip Arthroplasties, Bariatric, and Kidney Transplant Surgeries

A NA study, sponsored by Jacques E. Chelly.

Completed
Registry status
NA
Development phase
20
Enrollment target

NCT03834142 is a NA study that has completed, run by Jacques E. Chelly. The registered enrollment target is 20 participants.

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The verdict

NCT03834142, a NA study, has completed, sponsored by Jacques E. Chelly.

COMPLETED
Registry status
NA
Development phase
20 participants
Enrollment target

Study Summary

The current opioid epidemic has led to a renewed interest in exploring non-pharmacological techniques to treat post-operative pain. An increasing number of patients are suffering from the adverse effects of opioid use following surgery, including post-operative nausea and vomiting, respiratory depression, immunosuppression, constipation, and most recently, addiction. In the United States, over $600 billion is spent every year on opioid addiction, including $79 billion related to opioid addiction following surgery. Despite many initiatives to decrease the use of opiates in the preoperative setting, opioids continue to be regularly prescribed before, during and after surgery. Although the risk of opioid addiction following surgery is recognized, the percentage of patients becoming addicted to opioids following surgery is not well understood. To date, there has been virtually no agreement regarding the duration and dosage that qualify for opioid dependence following surgery, nor that a clear estimation of the factors such as biological, psychosocial and socioeconomic that increase the risk of using opioids for extended periods of time after surgery. Therefore, in order to combat this growing health crisis at the ground level, it is incumbent upon the medical community to explore alternative methods of pain control to treat the surgical population in order to change the incidence of post-operative opioid addiction. Percutaneous Nerve Field Stimulation (PNFS) is one of these recognized methods that ongoing research has shown to be effective as a complementary method of pain management. While PNFS is not a novel concept, clinical indications of auricular field stimulation have been limited in the past due to requirement of bulky, stationary and non-disposable stimulators and electrodes. These technological limitations made it difficult to establish the real clinical potential of auricular stimulation for the perioperative management of pain in surgical patients, despite

Interventions

  • DEVICE NSS-2 Bridge

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2019-03-08
Est. Completion 2021-06-30
Phase NA

Sponsor

Jacques E. Chelly

10 total trials

What the Registry Record Tells You About NCT03834142

The ClinicalTrials.gov registry entry for NCT03834142 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Jacques E. Chelly, which has 10 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which NSS-2 Bridge is the first listed.

NCT03834142 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03834142 about?

NCT03834142 is a clinical study titled "NSS-2-BRIDGE Study for Total Knee and Hip Arthroplasties, Bariatric, and Kidney Transplant Surgeries". The current opioid epidemic has led to a renewed interest in exploring non-pharmacological techniques to treat post-operative pain. An increasing number of patients are suffering from the adverse effects of opioid use following surgery, including post-operative nausea and vomiting, respiratory depre...

What is the current status of trial NCT03834142?

This trial is currently completed. It is a NA study. The enrollment target is 20 participants. The study started on 2019-03-08. Estimated completion is 2021-06-30.

What interventions are being tested in trial NCT03834142?

The interventions under investigation include: NSS-2 Bridge (DEVICE).

Who is sponsoring clinical trial NCT03834142?

This trial is sponsored by Jacques E. Chelly, which has 10 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.