An interventional study of BRIDGE device in Liver Failure, Liver Diseases, Alcoholic and Liver Diseases, sponsored by Duke University. Terminated at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-05-29.
Sponsored by Duke University · Not applicable, Interventional, and Treatment
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.
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
Inclusion Criteria:
Inclusion criteria:
Exclusion Criteria:
BRIDGE device will be placed prior to start of the surgery with standard of care pain control analgesia
Device: BRIDGE device
Subjects will receive the standard of care pain control analgesia
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
Opioid Usage After Surgery as Measured by Total Milligrams of Morphine or Equivalent (MEQ)
Comparison between study groups (BRIDGE device vs. Standard of Care)
Time frame: up to day 30
Pain Level
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.
Time frame: up to day 30
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). Clinically important PONV is defined as a total score ≥50 at any time throughout the study period. Scale is 0 to infinity.
Time frame: up to day 30
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) 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.
Time frame: up to day 30
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 5
Incidence of Post-operative Ileus Will be Measured by Number of Participants Who Need Nasogastric Decompression for >48 Hours
Determination of the presence of an ileus in the two groups (SOC and with device)
Time frame: up to 48 hours
Number of Participants Who Reported Post-operative Mobility Issues 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
Average Length of Hospital Stay
Determination of length of hospital stay with in the two groups (SOC and with device)
Time frame: up to 30 days
Time to Physical Function
Time to physical function measured by survey
Time frame: 24 hours after device has been removed
Incidence of Complications
Complications related to pain control after the device is removed.
Time frame: 24 hours after device has been removed
Number of Participants Who Were Re-hospitalized
Time frame: up to 30 days
| Milestone | BRIDGE Device | Standard of Care |
|---|---|---|
| Started | 12 | 15 |
| Completed | 12 | 14 |
| Not completed | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 1 |
Comparison between study groups (BRIDGE device vs. Standard of Care)
| milligrams morphine or equivalent (MEQ) | BRIDGE Device | Standard of Care |
|---|---|---|
| Opioid Usage After Surgery as Measured by Total Milligrams of Morphine or Equivalent (MEQ) | 51.1 (36.6 to 65.6) | 45.4 (32.4 to 58.3) |
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.
| units on a scale | BRIDGE Device | Standard of Care |
|---|---|---|
| Pain Level | 6.6 (0 to 10) | 5.0 (0 to 10) |
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.
| score on a scale | BRIDGE Device | Standard of Care |
|---|---|---|
| Baseline | — | 96 |
| 6-12 hours post-op | 3 | 0 |
| 12-24 hours post-op | — | 275 |
| 24-48 hours post-op | 0 | 0 |
| Day 30 post-op | — | 1 |
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.
| participants | BRIDGE Device | Standard of Care |
|---|---|---|
| Reduction in Vomiting Scores as Measured by a 4-item Questionnaire Response | 2 | 1 |
Evaluation of return of bowel function noting day of bowel movement occurrence in both groups.
| Days post-surgery | BRIDGE Device | Standard of Care |
|---|---|---|
| Reduction in Time for Return of Bowel Function as Measured by Length to Time of Bowel Functioning Return. | 3 ± 1.65 | 2 ± 1.51 |
Determination of the presence of an ileus in the two groups (SOC and with device)
| Participants | BRIDGE Device | Standard of Care |
|---|---|---|
| Incidence of Post-operative Ileus Will be Measured by Number of Participants Who Need Nasogastric Decompression for >48 Hours | 0 | 0 |
Determination of mobility with in the two groups (SOC and with device)
| Participants | BRIDGE Device | Standard of Care |
|---|---|---|
| Number of Participants Who Reported Post-operative Mobility Issues as Measured by the Patient Symptom Surveys | 2 | 7 |
Determination of length of hospital stay with in the two groups (SOC and with device)
| days | BRIDGE Device | Standard of Care |
|---|---|---|
| Average Length of Hospital Stay | 7.7 (4 to 13) | 8 (5 to 15) |
Time to physical function measured by survey
No measurements were reported for this outcome.
Complications related to pain control after the device is removed.
| Participants | BRIDGE Device |
|---|---|
| Incidence of Complications | 0 |
| Participants | BRIDGE Device | Standard of Care |
|---|---|---|
| Number of Participants Who Were Re-hospitalized | 3 | 1 |
Collected over Up to 30 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| BRIDGE Device | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| Standard of Care | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
| Age, Continuous(years) | BRIDGE Device | Standard of Care | Total |
|---|---|---|---|
| Mean | 56.81 ± 10.17 | 55.98 ± 10.57 | 56.40 ± 10.37 |
| Sex: Female, Male(Participants) | BRIDGE Device | Standard of Care | Total |
|---|---|---|---|
| Female | 5 | 4 | 9 |
| Male | 7 | 11 | 18 |
| Ethnicity (NIH/OMB)(Participants) | BRIDGE Device | Standard of Care | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 0 | 1 |
| Not Hispanic or Latino | 11 | 15 | 26 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | BRIDGE Device | Standard of Care | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 3 | 0 | 3 |
| White | 9 | 15 | 24 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | BRIDGE Device | Standard of Care | Total |
|---|---|---|---|
| United States | 12 | 15 | 27 |
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Duke University