Pain, Postoperative Clinical Trial
— BRIDGEOfficial title:
Auricular Percutaneous Electrical Nerve Field Stimulation (PENFS) Using the BRIDGE Device for Post-Operative Pain Control in Patients Undergoing Liver Transplantation
Verified date | January 2023 |
Source | Duke University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 27 |
Est. completion date | April 3, 2020 |
Est. primary completion date | April 3, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Duke University | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Duke University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Opioid Usage After Surgery as Measured by Total Milligrams of Morphine or Equivalent (MEQ) | up to day 30 | ||
Secondary | Pain Level | Evaluation of the pain score in the two groups (SOC and with device) at the end of surgery | up to day 30 | |
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) | 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) | 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. | up to day 30 | |
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) | up to 30 days | |
Secondary | Improved Post-operative Mobility as Measured by the Patient Symptom Surveys | Determination of mobility with in the two groups (SOC and with device) | up to 30 days | |
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) | up to 30 days |
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