Auricular Percutaneous Electrical Nerve Field Stimulation (PENFS) Using the BRIDGE Device for Post-Operative Pain Control in Patients Undergoing Liver Transplantation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Liver Failure
- Sponsor
- Duke University
- Enrollment
- 27
- Locations
- 1
- Primary Endpoint
- Opioid Usage After Surgery as Measured by Total Milligrams of Morphine or Equivalent (MEQ)
- Status
- Terminated
- Last Updated
- 3 years ago
Overview
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 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.
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 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
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Opioid Usage After Surgery as Measured by Total Milligrams of Morphine or Equivalent (MEQ)
Time Frame: up to day 30
Secondary Outcomes
- Pain Level(up to day 30)
- Reduction in Nausea Scores as Measured by a 4-item Questionnaire Response(up to day 30)
- Reduction in Vomiting Scores as Measured by a 4-item Questionnaire Response(up to day 30)
- Incidence of Post-operative Ileus Will be Measured by Need for Nasogastric Decompression for >48 Hours(up to 30 days)
- Reduction in Time for Return of Bowel Function as Measured by Length to Time of Bowel Functioning Return.(up to day 30)
- Improved Post-operative Mobility as Measured by the Patient Symptom Surveys(up to 30 days)
- Reduction in Length of Hospital Stay as Measured by Days in Hospital(up to 30 days)