Actively Recruiting
Use of Transcutaneous Electrical Nerve Stimulation Device, Reletex Reliefband, With Current ERAS (Enhanced Recovery After Surgery) Protocol to Further Decrease Postoperative Nausea and Vomiting in the Bariatric Surgical Patient Within the First 24 Hours Postoperatively.
Led by University of Pennsylvania · Updated on 2025-11-26
100
Participants Needed
1
Research Sites
34 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Use of Transcutaneous Electrical Nerve Stimulation Device, Reletex Reliefband, With Current ERAS (Enhanced Recovery After Surgery) Protocol to Further Decrease Postoperative Nausea and Vomiting in the Bariatric Surgical Patient Within the First 24 Hours Postoperatively.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 to 75 years old
- Body mass index (BMI) of 35 or greater
- Eligible for and undergoing robotic sleeve gastrectomy surgery
- Able to provide informed consent independently
You will not qualify if you...
- Diagnosis of gastroparesis
- Pregnancy
- Having a cardiac pacemaker, defibrillator, or intrathecal pump
- Current smoker or tobacco use within 30 days before surgery
- Known allergy to conductivity gel
- Unable to understand or follow surgery-related long-term restrictions due to altered mentation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Princeton Hospital
Plainsboro, New Jersey, United States, 08536
Actively Recruiting
Research Team
D
Donna L Post, Bariatric Coordinator/Nurse Navigator, BSN
CONTACT
L
Lisa Dobruskin, MD Medical Director Penn Med Princeton Bariatrics, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here