The goal of this clinical trial is to learn if the Reletex Reliefband device when used in conjunction with our current treatments will further decrease postoperative nausea and vomiting. The Investigators want to test how well it works, specifically in bariatric surgery patients that are at a higher risk for nausea and vomiting after surgery. Furthermore, the investigators would like to see if using this non-drug treatment option might allow for the same or better control of nausea and vomiting with fewer side effects than the current medications used. This may decrease drowsiness, and allow for earlier mobility, increase comfort, and generally accelerate recovery after surgery.
The main questions it aims to answer are:
* Does the use of Reletex Reliefband decrease postoperative nausea and vomiting (PONV) in the Bariatric surgical patient, therefore decreasing need for additional anti-emetics. * Does the use of Reletex Reliefband the use of the Reletex Reliefband during the immediate post-operative period reduce PONV, allowing for early mobility, decreased pain and length of stay (LOS). * Does the use of Reletex Reliefband decrease the use of medications for nausea and therefore decrease costs. * Does the use of Reletex Reliefband reduce prolonged PONV and therefore prevent the downstream effects, i.e. less mobility, increased pain, inhibit the patients' ability to comply with recommended treatments. * If reducing PONV using non-pharmaceutical approaches will improve outcomes and patient experiences.
Researchers will compare to a placebo (a look-alike device) to see if the Reletex Reliefband works to decrease PONV.
Participants will:
* All receive the standard Enhanced Recovery After Surgery (ERAS) Protocol before, during and after surgery. (This includes use of premedications for pain, and nausea) * Have a band applied and turned on at the completion of the patient's bariatric sleeve surgery. The band will be adjusted based on need and worn for a total of 24 hours postoperatively. * Have a pedometer clipped to their gown, to remain in place for 24 hours postoperatively * Be assessed regularly during their hospital stay by the nurses to monitor the site of the band, their level of nausea/vomiting, pain levels, and level of mobility
Adults 18-75 years of age
BMI 35 or greater
Patients eligible for and undergoing a Robotic Sleeve Gastrectomy
Able to consent on own behalf
A diagnosis of gastroparesis
Pregnancy
Presence of a cardiac pacemaker/defibrillator or intrathecal pump
Current smoker or tobacco use within 30 days of procedure.
Parallel
Wearable Transcutaneous electrical Nerve Stimulation unit to mitigate postoperative nausea and vomiting (PONV) in the Bariatric Surgical Patient
DeviceUse of a wearable device, which emits a low-level electric current across 2 small electrodes on the underside of the patient's wrist, stimulating the nerves and sending a signal to the center of the brain that can help suppress nausea/vomiting. A review of the medical literature found studies that found the device to be effective in reducing PONV. It has been studied in the past, but the trials had limitations, not double blinded and no true placebo. We have proposed a true double blind randomized study utilizing a placebo which specifically mimics the actual device as closely as possible to prevent bias and adversely effecting data results. Nor had this device been tested specifically in the postop bariatric surgical patient.
A sham device that will mimic the active wearable device. It will look the same, and buzz but will not actually admit a low-leve electric current that would stimulate the nerves.
DeviceThe company who makes the active device created a sham wearable device that looks like the active, and buzzes (to give the feel of stimulation), but does not actual emit a low-leve electrical signal to stimulate the nerves.
Post operative nausea and vomiting (PONV) incidents utilizing the PONV impact scale in placebo/sham vs active group.
Evaluate the effectiveness of utilizing the Reletex Reliefband to decrease incidence of postoperative nausea and vomiting (PONV). This would be measured using the PONV impact scale and taking an average of this throughout the 24 hour period for all participants. Our end point goal would be that those with the active device would have an average PONV score of \<5 indicating minimal PONV.
Participants w/active wearable device to prevent PONV will have a reduced need for additional anti-emetics. This will be measured by looking at the average number of anti-emetics given as needed for the first 24 hours in both arms.
Participants from both arms of the study will receive premedications to prevent PONV. Then postoperatively they will be assessed for need of additional medications, based on PONV impact score.
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University of Pennsylvania
Lead sponsor
Penn Medicine Princeton Health
Sponsor institution
