Liver Cirrhosis, Biliary, Liver Diseases, Liver Diseases, Alcoholic, Liver Failure, Pain, Postoperative, Transplant; Failure, Liver
Conditions
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
Interventions
DEVICEBRIDGE 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
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Two groups where randomization is either to device or SOC (standard of care)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Usage After Surgery as Measured by Total Milligrams of Morphine or Equivalent (MEQ) | up to day 30 | Comparison between study groups (BRIDGE device vs. Standard of Care) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Level | up to day 30 | Evaluation of the pain score in the two groups (SOC and with device) at the end of surgery. The Numeric Pain Rating Scale (NPRS) ranges from 0-10, and higher scores indicate greater pain. |
| Reduction in Nausea Scores as Measured by a 4-item Questionnaire Response | up to day 30 | Determination of the intensity of nausea in the two groups (SOC and with device). Clinically important PONV is defined as a total score ≥50 at any time throughout the study period. Scale is 0 to infinity. |
| Reduction in Vomiting Scores as Measured by a 4-item Questionnaire Response | up to day 30 | Determination of the intensity of vomiting in the two groups (SOC and with device) using the Simplified Postoperative Nausea and Vomiting Impact Scale, where the choices are: No, Sometimes, Often of most of the time, and All of the time. |
| Reduction in Time for Return of Bowel Function as Measured by Length to Time of Bowel Functioning Return. | up to day 5 | Evaluation of return of bowel function noting day of bowel movement occurrence in both groups. |
| Incidence of Post-operative Ileus Will be Measured by Number of Participants Who Need Nasogastric Decompression for >48 Hours | up to 48 hours | Determination of the presence of an ileus in the two groups (SOC and with device) |
| Number of Participants Who Reported Post-operative Mobility Issues as Measured by the Patient Symptom Surveys | up to 30 days | Determination of mobility with in the two groups (SOC and with device) |
| Average Length of Hospital Stay | up to 30 days | Determination of length of hospital stay with in the two groups (SOC and with device) |
| Time to Physical Function | 24 hours after device has been removed | Time to physical function measured by survey |
| Incidence of Complications | 24 hours after device has been removed | Complications related to pain control after the device is removed. |
| Number of Participants Who Were Re-hospitalized | up to 30 days | — |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAlicia Mavis, MD
Duke Universtity
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| BRIDGE Device BRIDGE device will be placed prior to start of the surgery with standard of care pain control analgesia
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 | 12 |
| Standard of Care Subjects will receive the standard of care pain control analgesia | 15 |
| Total | 27 |
Baseline characteristics
| Characteristic | BRIDGE Device | Total | Standard of Care |
|---|---|---|---|
| Age, Continuous | 56.81 years STANDARD_DEVIATION 10.17 | 56.40 years STANDARD_DEVIATION 10.37 | 55.98 years STANDARD_DEVIATION 10.57 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 11 Participants | 26 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 9 Participants | 24 Participants | 15 Participants |
| Region of Enrollment United States | 12 Participants | 27 Participants | 15 Participants |
| Sex: Female, Male Female | 5 Participants | 9 Participants | 4 Participants |
| Sex: Female, Male Male | 7 Participants | 18 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 15 |
| other Total, other adverse events | 0 / 12 | 0 / 15 |
| serious Total, serious adverse events | 0 / 12 | 0 / 15 |
Outcome results
Primary
Opioid Usage After Surgery as Measured by Total Milligrams of Morphine or Equivalent (MEQ)
Time frame: up to day 30
| Arm | Measure | Value (MEAN) |
|---|---|---|
| BRIDGE Device | Opioid Usage After Surgery as Measured by Total Milligrams of Morphine or Equivalent (MEQ) | 51.1 milligrams morphine or equivalent (MEQ) |
| Standard of Care | Opioid Usage After Surgery as Measured by Total Milligrams of Morphine or Equivalent (MEQ) | 45.4 milligrams morphine or equivalent (MEQ) |
p-value: 0.895% CI: [-17.5, 29]Mixed Models Analysis
Secondary
Improved Post-operative Mobility as Measured by the Patient Symptom Surveys
Determination of mobility with in the two groups (SOC and with device)
Time frame: up to 30 days
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)
Time frame: up to 30 days
Secondary
Pain Level
Evaluation of the pain score in the two groups (SOC and with device) at the end of surgery
Time frame: up to day 30
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)
Time frame: up to 30 days
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)
Time frame: 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.
Time frame: 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)
Time frame: up to day 30