NCT03265249

BRIDGE Device for Post-operative Pain Control

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Conditions

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

Interventions

Type	Name	Description
DEVICE	BRIDGE 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

Timeline

• Start date: 2018-02-12
• Primary completion: 2020-04-03
• Completion: 2020-04-03
• First posted: 2017-08-29
• Last updated: 2023-03-08
• Results posted: 2023-03-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study