TerminatedNot Applicable

BRIDGE Device for Post-operative Pain Control

Stopped: slow enrollment

United States27 participantsStarted 2018-02-12

Plain-language summary

Auricular neurostimulation is a potential novel and non-invasive method of pain control following liver transplantation in a growing patient population with the probability of significant impact on economics and morbidity. The investigators propose a pilot study to investigate the effects of auricular neurostimulation in patients receiving a liver transplantation. The investigator will investigate the effects of auricular neurostimulation with this novel device and compare it to the current standard of care for pain management following liver transplantation.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Inclusion criteria: * ≥18 years of age but \<70 years of age * Actively listed for isolated liver transplantation * Subject or legally authorized representative able to sign informed consent * Not currently treated with opioids or any medications that may interact with opioids * English speaking * Willing and able to participate and consent to this study Exclusion Criteria: * Diagnosis of acute liver failure or primary sclerosing cholangitis (PSC) * Anticipated that the subject will require a new roux-en-y hepaticojejunostomy * Current use of opioid use or other substance abuse. * Chronic pain disorders * Need for regional anesthesia (regional nerve blocks or epidurals) * Adhesive allergy/sensitivity * Subject admitted to the ICU at the time of transplant

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Opioid Usage After Surgery as Measured by Total Milligrams of Morphine or Equivalent (MEQ)

Timeframe: up to day 30

Trial details

NCT IDNCT03265249

SponsorDuke University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-04-03

Results submitted2023-01-30

View on ClinicalTrials.gov More Liver Failure trials