About this trial
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
Eligibility criteria
Qualifiers
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
Disqualifiers
A diagnosis of gastroparesis
Pregnancy
Presence of a cardiac pacemaker/defibrillator or intrathecal pump
Current smoker or tobacco use within 30 days of procedure.
Trial design
Treatments tested in this trial
- Wearable Transcutaneous electrical Nerve Stimulation unit to mitigate postoperative nausea and vomiting (PONV) in the 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.
Treatment groups
Sponsors and collaborators
University of Pennsylvania
Lead sponsor
Penn Medicine Princeton Health
Sponsor institution