BRIDGE Device for Post-operative Pain Control
| Status: | Recruiting |
|---|---|
| Conditions: | Post-Surgical Pain, Gastrointestinal, Gastrointestinal, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 11/10/2018 |
| Start Date: | February 12, 2018 |
| End Date: | October 1, 2028 |
| Contact: | Brittany Rowley, BS |
| Email: | brittany.rowley@duke.edu |
| Phone: | 919-668-3426 |
Auricular Percutaneous Electrical Nerve Field Stimulation (PENFS) Using the BRIDGE Device for Post-Operative Pain Control in Patients Undergoing Liver Transplantation
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.
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.
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
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
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
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