BRIDGE Device for Post-operative Pain Control

Duke University

Status: Terminated

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

Treatments: Device: BRIDGE device

Study type: Interventional

Funder types: Other

Identifiers

NCT03265249

Pro00084620

Details and patient eligibility

About

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.

Full 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

Enrollment: 27 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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27 participants in 2 patient groups

Group 1

Experimental group

Description:

BRIDGE device will be placed prior to start of the surgery with standard of care pain control analgesia

Treatment:

Device: BRIDGE device

Group 2

No Intervention group

Description:

Subjects will receive the standard of care pain control analgesia