Status:
TERMINATED
BRIDGE Device for Post-operative Pain Control
Lead Sponsor:
Duke University
Conditions:
Liver Failure
Liver Diseases, Alcoholic
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief 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 ec...
Detailed Description
This is a prospective, randomized study to determine the efficacy of the BRIDGE device in reducing pain and opioid use in patients following liver transplantation. Subjects will be randomized in a 1:1...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 3 2020
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT03265249
Start Date
February 12 2018
End Date
April 3 2020
Last Update
March 8 2023
Active Locations (1)
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1
Duke University
Durham, North Carolina, United States, 27705