BRIDGE Device for Post-operative Pain Control

Study Overview
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Brief Summary
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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
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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

Official Title
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Auricular Percutaneous Electrical Nerve Field Stimulation (PENFS) Using the BRIDGE Device for Post-Operative Pain Control in Patients Undergoing Liver Transplantation

Conditions
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Liver Failure, Liver Diseases, Alcoholic, Liver Diseases, Pain, Postoperative, Transplant; Failure, Liver, Liver Cirrhosis, Biliary

Intervention / Treatment
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* Device: BRIDGE device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two groups where randomization is either to device or SOC (standard of care)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>BRIDGE device will be placed prior to start of the surgery with standard of care pain control analgesia | Device: BRIDGE device<br>* 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<br>|
| No Intervention: Group 2<br>Subjects will receive the standard of care pain control analgesia | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid Usage After Surgery as Measured by Total Milligrams of Morphine or Equivalent (MEQ) |  | up to day 30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Level | Evaluation of the pain score in the two groups (SOC and with device) at the end of surgery | 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) | 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) | 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. | 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) | 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) | 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) | up to 30 days |