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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
27
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
Duke University
Durham, North Carolina, United States
Opioid Usage After Surgery as Measured by Total Milligrams of Morphine or Equivalent (MEQ)
Time frame: up to day 30
Pain Level
Evaluation of the pain score in the two groups (SOC and with device) at the end of surgery
Time frame: up to day 30
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)
Time frame: up to day 30
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)
Time frame: up to day 30
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.
Time frame: up to day 30
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)
Time frame: up to 30 days
Improved Post-operative Mobility as Measured by the Patient Symptom Surveys
Determination of mobility with in the two groups (SOC and with device)
Time frame: up to 30 days
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)
Time frame: up to 30 days
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