Back to resultsBRIDGE Device for Post-operative Pain Control (BRIDGE)
Primary Purpose
Liver Failure, Liver Diseases, Alcoholic, Liver Diseases
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BRIDGE device
Sponsored by
About this trial
This is an interventional treatment trial for Liver Failure
Eligibility Criteria
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
Sites / Locations
- Duke University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Group 1
Group 2
Arm Description
BRIDGE device will be placed prior to start of the surgery with standard of care pain control analgesia
Subjects will receive the standard of care pain control analgesia
Outcomes
Primary Outcome Measures
Opioid Usage After Surgery as Measured by Total Milligrams of Morphine or Equivalent (MEQ)
Secondary Outcome Measures
Pain Level
Evaluation of the pain score in the two groups (SOC and with device) at the end of surgery
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)
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)
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.
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)
Improved Post-operative Mobility as Measured by the Patient Symptom Surveys
Determination of mobility with in the two groups (SOC and with device)
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03265249
Brief Title
BRIDGE Device for Post-operative Pain Control
Acronym
BRIDGE
Official Title
Auricular Percutaneous Electrical Nerve Field Stimulation (PENFS) Using the BRIDGE Device for Post-Operative Pain Control in Patients Undergoing Liver Transplantation
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Terminated
Why Stopped
slow enrollment
Study Start Date
February 12, 2018 (Actual)
Primary Completion Date
April 3, 2020 (Actual)
Study Completion Date
April 3, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Failure, Liver Diseases, Alcoholic, Liver Diseases, Pain, Postoperative, Transplant; Failure, Liver, Liver Cirrhosis, Biliary
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two groups where randomization is either to device or SOC (standard of care)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Experimental
Arm Description
BRIDGE device will be placed prior to start of the surgery with standard of care pain control analgesia
Arm Title
Group 2
Arm Type
No Intervention
Arm Description
Subjects will receive the standard of care pain control analgesia
Intervention Type
Device
Intervention Name(s)
BRIDGE device
Intervention Description
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 Outcome Measure Information:
Title
Opioid Usage After Surgery as Measured by Total Milligrams of Morphine or Equivalent (MEQ)
Time Frame
up to day 30
Secondary Outcome Measure Information:
Title
Pain Level
Description
Evaluation of the pain score in the two groups (SOC and with device) at the end of surgery
Time Frame
up to day 30
Title
Reduction in Nausea Scores as Measured by a 4-item Questionnaire Response
Description
Determination of the intensity of nausea in the two groups (SOC and with device)
Time Frame
up to day 30
Title
Reduction in Vomiting Scores as Measured by a 4-item Questionnaire Response
Description
Determination of the intensity of vomiting in the two groups (SOC and with device)
Time Frame
up to day 30
Title
Reduction in Time for Return of Bowel Function as Measured by Length to Time of Bowel Functioning Return.
Description
Evaluation of return of bowel function noting day of bowel movement occurrence in both groups.
Time Frame
up to day 30
Title
Incidence of Post-operative Ileus Will be Measured by Need for Nasogastric Decompression for >48 Hours
Description
Determination of the presence of an ileus in the two groups (SOC and with device)
Time Frame
up to 30 days
Title
Improved Post-operative Mobility as Measured by the Patient Symptom Surveys
Description
Determination of mobility with in the two groups (SOC and with device)
Time Frame
up to 30 days
Title
Reduction in Length of Hospital Stay as Measured by Days in Hospital
Description
Determination of length of hospital stay with in the two groups (SOC and with device)
Time Frame
up to 30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alicia Mavis, MD
Organizational Affiliation
Duke Universtity
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
12. IPD Sharing Statement
Learn more about this trial
BRIDGE Device for Post-operative Pain Control
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