BRIDGE Device for Post-operative Pain Control

Pain, Postoperative Clinical Trial

— BRIDGE  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03265249
• Other study ID #: Pro00084620
• Status: Terminated
• Phase: N/A
• Start date: February 12, 2018
• Est. completion date: April 3, 2020

Study information

• Verified date: January 2023
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 27
• Est. completion date: April 3, 2020
• Est. primary completion date: April 3, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opioid Usage After Surgery as Measured by Total Milligrams of Morphine or Equivalent (MEQ)		up to day 30
Secondary	Pain Level	Evaluation of the pain score in the two groups (SOC and with device) at the end of surgery	up to day 30
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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