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BRIDGE Device for Post-operative Pain Control (BRIDGE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03265249
Recruitment Status : Suspended (COVID-19 Restrictions)
First Posted : August 29, 2017
Last Update Posted : May 21, 2020
Sponsor:
Information provided by (Responsible Party):
Duke University

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 investigator 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.

Condition or disease Intervention/treatment Phase
Liver Failure Liver Diseases, Alcoholic Liver Diseases Pain, Postoperative Transplant; Failure, Liver Liver Cirrhosis, Biliary Device: BRIDGE device Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: two groups where randomization is either to device or SOC
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Auricular Percutaneous Electrical Nerve Field Stimulation (PENFS) Using the BRIDGE Device for Post-Operative Pain Control in Patients Undergoing Liver Transplantation
Actual Study Start Date : February 12, 2018
Estimated Primary Completion Date : October 1, 2028
Estimated Study Completion Date : October 1, 2028

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group 1
BRIDGE device will be placed prior to start of the surgery with standard of care pain control analgesia
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

No Intervention: Group 2
Subjects will receive the standard of care pain control analgesia



Primary Outcome Measures :
  1. opioid usage after surgery as measured by based on daily number of doses and total morphine equivalents used at different time points during the post-operative course. [ Time Frame: up to day 30 ]
    Determination of the usage of opioid usage after surgery in the two groups being SOC and with device.


Secondary Outcome Measures :
  1. Pain level [ Time Frame: up to day 30 ]
    Evaluation of the pain score in the two groups (SOC and with device) at the end of surgery

  2. reduction in nausea scores as measured by a 4-item questionnaire response [ Time Frame: up to day 30 ]
    Determination of the intensity of nausea in the two groups (SOC and with device)

  3. reduction in vomiting scores as measured by a 4-item questionnaire response [ Time Frame: up to day 30 ]
    Determination of the intensity of vomiting in the two groups (SOC and with device)

  4. Reduction in time for return of bowel function as measured by length to time of bowel functioning return. [ Time Frame: up to day 30 ]
    Evaluation of return of bowel function noting day of bowel movement occurrence in both groups.

  5. Incidence of post-operative ileus will be measured by need for nasogastric decompression for >48 hours [ Time Frame: up to 30 days ]
    Determination of the presence of an ileus in the two groups (SOC and with device)

  6. Improved post-operative mobility as measured by the patient symptom surveys [ Time Frame: up to 30 days ]
    Determination of mobility with in the two groups (SOC and with device)

  7. Reduction in length of hospital stay as measured by days in hospital [ Time Frame: up to 30 days ]
    Determination of length of hospital stay with in the two groups (SOC and with device)



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03265249


Locations
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United States, North Carolina
Duke University
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Alicia Mavis, MD Duke Universtity
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03265249    
Other Study ID Numbers: Pro00084620
First Posted: August 29, 2017    Key Record Dates
Last Update Posted: May 21, 2020
Last Verified: May 2020

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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
Additional relevant MeSH terms:
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Liver Diseases
Liver Cirrhosis
Liver Failure
Liver Cirrhosis, Biliary
Liver Diseases, Alcoholic
Pain, Postoperative
Pathologic Processes
Digestive System Diseases
Postoperative Complications
Pain
Neurologic Manifestations
Signs and Symptoms
Hepatic Insufficiency
Cholestasis, Intrahepatic
Cholestasis
Bile Duct Diseases
Biliary Tract Diseases
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders