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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03265249
Other study ID # Pro00084620
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date February 12, 2018
Est. completion date April 3, 2020

Study information

Verified date January 2023
Source Duke University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 ration to one of the below groups: Group 1: BRIDGE device will be placed prior to start of the surgery with standard of care pain control analgesia Group 2: Subjects will receive the standard of care pain control analgesia


Recruitment information / eligibility

Status Terminated
Enrollment 27
Est. completion date April 3, 2020
Est. primary completion date April 3, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Study Design


Intervention

Device:
BRIDGE device
an externally placed, FDA-cleared device that delivers percutaneous electrical stimulation with alternating frequencies to branches of cranial nerves (V, VII, IX, and X) through the external ear via a field effect

Locations

Country Name City State
United States Duke University Durham North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Opioid Usage After Surgery as Measured by Total Milligrams of Morphine or Equivalent (MEQ) up to day 30
Secondary Pain Level Evaluation of the pain score in the two groups (SOC and with device) at the end of surgery up to day 30
Secondary Reduction in Nausea Scores as Measured by a 4-item Questionnaire Response Determination of the intensity of nausea in the two groups (SOC and with device) up to day 30
Secondary Reduction in Vomiting Scores as Measured by a 4-item Questionnaire Response Determination of the intensity of vomiting in the two groups (SOC and with device) up to day 30
Secondary Reduction in Time for Return of Bowel Function as Measured by Length to Time of Bowel Functioning Return. Evaluation of return of bowel function noting day of bowel movement occurrence in both groups. up to day 30
Secondary Incidence of Post-operative Ileus Will be Measured by Need for Nasogastric Decompression for >48 Hours Determination of the presence of an ileus in the two groups (SOC and with device) up to 30 days
Secondary Improved Post-operative Mobility as Measured by the Patient Symptom Surveys Determination of mobility with in the two groups (SOC and with device) up to 30 days
Secondary Reduction in Length of Hospital Stay as Measured by Days in Hospital Determination of length of hospital stay with in the two groups (SOC and with device) up to 30 days
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