Clinical trial NCT03265249: BRIDGE Device for Post-operative Pain Control
Official title: Auricular Percutaneous Electrical Nerve Field Stimulation (PENFS) Using the BRIDGE Device for Post-Operative Pain Control in Patients Undergoing Liver Transplantation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Liver Failure
Liver Diseases, Alcoholic
Liver Diseases
Pain, Postoperative
Transplant; Failure, Liver
Liver Cirrhosis, Biliary
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2017-08-29
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups where randomization is either to device or SOC (standard of care)
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Opioid Usage After Surgery as Measured by Total Milligrams of Morphine or Equivalent (MEQ)
timeFrame: up to day 30
Secondary outcomes:
measure: Pain Level
timeFrame: up to day 30
measure: Reduction in Nausea Scores as Measured by a 4-item Questionnaire Response
timeFrame: up to day 30
measure: Reduction in Vomiting Scores as Measured by a 4-item Questionnaire Response
timeFrame: up to day 30
measure: Reduction in Time for Return of Bowel Function as Measured by Length to Time of Bowel Functioning Return.
timeFrame: up to day 30
measure: Incidence of Post-operative Ileus Will be Measured by Need for Nasogastric Decompression for >48 Hours
timeFrame: up to 30 days
measure: Improved Post-operative Mobility as Measured by the Patient Symptom Surveys
timeFrame: up to 30 days
measure: Reduction in Length of Hospital Stay as Measured by Days in Hospital
timeFrame: up to 30 days
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Duke Universtity
name: Alicia Mavis, MD
role: PRINCIPAL_INVESTIGATOR
References: