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slow enrollment
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | BRIDGE device will be placed prior to start of the surgery with standard of care pain control analgesia |
|
| Group 2 | No Intervention | Subjects will receive the standard of care pain control analgesia |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BRIDGE device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid Usage After Surgery as Measured by Total Milligrams of Morphine or Equivalent (MEQ) | Comparison between study groups (BRIDGE device vs. Standard of Care) | up to day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to day 30 |
| Reduction in Nausea Scores as Measured by a 4-item Questionnaire Response |
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Inclusion Criteria:
Inclusion criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alicia Mavis, MD | Duke Universtity | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University | Durham | North Carolina | 27705 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Standard of Care | Subjects will receive the standard of care pain control analgesia |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Opioid Usage After Surgery as Measured by Total Milligrams of Morphine or Equivalent (MEQ) | Comparison between study groups (BRIDGE device vs. Standard of Care) | Posted | Mean | 95% Confidence Interval | milligrams morphine or equivalent (MEQ) | up to day 30 |
|
Up to 30 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alisha Mavis, M.D. | Duke University | 919-684-5068 | alisha.mavis@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 24, 2020 | Jan 30, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D017093 | Liver Failure |
| D008108 | Liver Diseases, Alcoholic |
| D008107 | Liver Diseases |
| D010149 | Pain, Postoperative |
| D008105 | Liver Cirrhosis, Biliary |
| ID | Term |
|---|---|
| D048550 | Hepatic Insufficiency |
| D004066 | Digestive System Diseases |
| D020751 | Alcohol-Induced Disorders |
| D019973 | Alcohol-Related Disorders |
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Two groups where randomization is either to device or SOC (standard of care)
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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. |
| 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. | 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. | 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) | 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) | up to 30 days |
| Average Length of Hospital Stay | Determination of length of hospital stay with in the two groups (SOC and with device) | up to 30 days |
| Time to Physical Function | Time to physical function measured by survey | 24 hours after device has been removed |
| Incidence of Complications | Complications related to pain control after the device is removed. | 24 hours after device has been removed |
| Number of Participants Who Were Re-hospitalized | up to 30 days |
| BG001 |
| Standard of Care |
Subjects will receive the standard of care pain control analgesia |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Secondary | 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. | Due to the study terminating, no statistical analyses were performed. | Posted | Mean | Full Range | units on a scale | up to day 30 |
|
|
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| 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). Clinically important PONV is defined as a total score ≥50 at any time throughout the study period. Scale is 0 to infinity. | Analysis population is participants who completed the PONV surveys and reported nausea at more than one time point. | Posted | Number | score on a scale | up to day 30 |
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|
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| 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) 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. | Due to the study terminating and missing data, no statistical analyses were performed. | Posted | Number | participants | up to day 30 |
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| 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. | Analysis population includes participants still on study at return of bowel function | Posted | Mean | Standard Deviation | Days post-surgery | up to day 5 |
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| Secondary | 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) | Posted | Count of Participants | Participants | up to 48 hours |
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| Secondary | 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) | Due to the study terminating and missing data, no statistical analyses were performed. | Posted | Count of Participants | Participants | up to 30 days |
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| Secondary | Average Length of Hospital Stay | Determination of length of hospital stay with in the two groups (SOC and with device) | Posted | Mean | Full Range | days | up to 30 days |
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| Secondary | Time to Physical Function | Time to physical function measured by survey | "Physical function" was not clearly defined in the protocol and none of the collected survey data provide that information. Due to the Principal Investigator leaving, the study terminating and undefined data, no data were collected or no data will ever be reported for this outcome, and no statistical analyses were performed. | Posted | 24 hours after device has been removed |
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| Secondary | Incidence of Complications | Complications related to pain control after the device is removed. | This outcome only applies to the BRIDGE device cohort | Posted | Count of Participants | Participants | 24 hours after device has been removed |
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| Secondary | Number of Participants Who Were Re-hospitalized | Posted | Count of Participants | Participants | up to 30 days |
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| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Standard of Care | Subjects will receive the standard of care pain control analgesia | 0 | 15 | 0 | 15 | 0 | 15 |
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| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D002780 | Cholestasis, Intrahepatic |
| D002779 | Cholestasis |
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
| D008103 | Liver Cirrhosis |
| D005355 | Fibrosis |
| 6-12 hours post-op |
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| 12-24 hours post-op |
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| 24-48 hours post-op |
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| 48-72 hours post-op |
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| Day 30 post-op |
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