BRIDGE Device for Post-operative Pain Control

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

• BRIDGE device (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

Primary outcomes

• Opioid Usage After Surgery as Measured by Total Milligrams of Morphine or Equivalent (MEQ) [up to day 30]: Comparison between study groups (BRIDGE device vs. Standard of Care)

Secondary outcomes

• Pain Level [up to day 30]: Evaluation of the pain score in the two groups (SOC and with device) at the end of surgery. The Numeric Pain Rating Scale (NPRS) ranges from 0-10, and higher scores indicate greater pain.
• Reduction in Nausea Scores as Measured by a 4-item Questionnaire Response [up to day 30]: Determination of the intensity of nausea in the two groups (SOC and with device). Clinically important PONV is defined as a total score ≥50 at any time throughout the study period. Scale is 0 to infinity.
• Reduction in Vomiting Scores as Measured by a 4-item Questionnaire Response [up to day 30]: Determination of the intensity of vomiting in the two groups (SOC and with device) using the Simplified Postoperative Nausea and Vomiting Impact Scale, where the choices are: No, Sometimes, Often of most of the time, and All of the time.
• Reduction in Time for Return of Bowel Function as Measured by Length to Time of Bowel Functioning Return. [up to day 5]: Evaluation of return of bowel function noting day of bowel movement occurrence in both groups.
• Incidence of Post-operative Ileus Will be Measured by Number of Participants Who Need Nasogastric Decompression for >48 Hours [up to 48 hours]: Determination of the presence of an ileus in the two groups (SOC and with device)
• Number of Participants Who Reported Post-operative Mobility Issues as Measured by the Patient Symptom Surveys [up to 30 days]: Determination of mobility with in the two groups (SOC and with device)
• Average Length of Hospital Stay [up to 30 days]: Determination of length of hospital stay with in the two groups (SOC and with device)
• Time to Physical Function [24 hours after device has been removed]: Time to physical function measured by survey
• Incidence of Complications [24 hours after device has been removed]: Complications related to pain control after the device is removed.
• Number of Participants Who Were Re-hospitalized [up to 30 days]

Sex: All, ages: 18 Years to 70 Years

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

Participant flow

Outcome results

• Opioid Usage After Surgery as Measured by Total Milligrams of Morphine or Equivalent (MEQ) (Primary), Mean, milligrams morphine or equivalent (MEQ): BRIDGE Device 51.1 (36.6 to 65.6); Standard of Care 45.4 (32.4 to 58.3) (p 0.80)
• Pain Level (Secondary), Mean, units on a scale: BRIDGE Device 6.6 (0 to 10); Standard of Care 5.0 (0 to 10)
• Reduction in Nausea Scores as Measured by a 4-item Questionnaire Response (Secondary), Number, score on a scale: BRIDGE Device ; Standard of Care 96
• Reduction in Vomiting Scores as Measured by a 4-item Questionnaire Response (Secondary), Number, participants: BRIDGE Device 2; Standard of Care 1
• Reduction in Time for Return of Bowel Function as Measured by Length to Time of Bowel Functioning Return. (Secondary), Mean, Days post-surgery: BRIDGE Device 3 +/- 1.65; Standard of Care 2 +/- 1.51
• Incidence of Post-operative Ileus Will be Measured by Number of Participants Who Need Nasogastric Decompression for >48 Hours (Secondary), Count of participants, Participants: BRIDGE Device 0; Standard of Care 0
• Number of Participants Who Reported Post-operative Mobility Issues as Measured by the Patient Symptom Surveys (Secondary), Count of participants, Participants: BRIDGE Device 2; Standard of Care 7
• Average Length of Hospital Stay (Secondary), Mean, days: BRIDGE Device 7.7 (4 to 13); Standard of Care 8 (5 to 15)
• Time to Physical Function (Secondary)
• Incidence of Complications (Secondary), Count of participants, Participants: BRIDGE Device 0
• Number of Participants Who Were Re-hospitalized (Secondary), Count of participants, Participants: BRIDGE Device 3; Standard of Care 1

Adverse events

Time frame: Up to 30 days

• Study Protocol and Statistical Analysis Plan (PDF, 2020-09-24)

• Alicia Mavis, MD, Principal investigator, Duke Universtity