BRIDGE Device for Post-operative Pain Control

NCT03265249 | Terminated Results FDA Device

• 1 other identifier: Pro00084620
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Opioid Usage After Surgery as Measured by Total Milligrams of Morphine or Equivalent (MEQ)

  up to day 30

Secondary Outcomes (7)

• 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

• Reduction in Time for Return of Bowel Function as Measured by Length to Time of Bowel Functioning Return.

  up to day 30

• Incidence of Post-operative Ileus Will be Measured by Need for Nasogastric Decompression for >48 Hours

  up to 30 days

Study Arms (2)

Group 1

EXPERIMENTAL

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

Device: BRIDGE device

Group 2

NO INTERVENTION

Subjects will receive the standard of care pain control analgesia

Interventions

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

Group 1

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Hepatic Insufficiency; Digestive System Diseases; Alcohol-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Cholestasis, Intrahepatic; Cholestasis; Bile Duct Diseases; Biliary Tract Diseases; Liver Cirrhosis; Fibrosis

Results Point of Contact

• Title: Alisha Mavis, M.D.
• Organization: Duke University

alisha.mavis@duke.edu

919-684-5068

Study Officials

• Alicia Mavis, MD

  Duke Universtity

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two groups where randomization is either to device or SOC (standard of care)

Study Record Dates

• First Submitted: August 22, 2017
• First Posted: August 29, 2017
• Study Start: February 12, 2018
• Primary Completion: April 3, 2020
• Study Completion: April 3, 2020
• Last Updated: March 8, 2023
• Results First Posted: March 8, 2023

Record last verified: 2023-01

Locations

US (1)