Use of Transcutaneous Electrical Nerve Stimulation Device, Reletex Reliefband to Decrease Postoperative Nausea and Vomiting in the Bariatric Surgical Patient

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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

Locations
United States
New Jersey
Princeton Hospital
RECRUITING
Plainsboro
Contact Information
Primary
Donna L Post, Bariatric Coordinator/Nurse Navigator, BSN
donna.post@pennmedicine.upenn.edu
609-423-8102
Backup
Lisa Dobruskin, MD Medical Director Penn Med Princeton Bariatrics, MD
yelizaveta.dobruskin@pennmedicine.upenn.edu
609-785-5870
Time Frame
Start Date: 2025-11-04
Estimated Completion Date: 2026-07
Participants
Target number of participants: 100
Treatments
Sham_comparator: Arm 1, will receive the placebo or sham device.
The sham device will mimic the actual device by looks, and feeling, but won't actually emit a low-level electric current to stimulate the nerves.
Active_comparator: Arm 2- will receive active band
This is the actual device, so it will emit a low-level electric current and stimulate the nerves of the patient.
Related Therapeutic Areas
Sponsors
Leads: University of Pennsylvania

This content was sourced from clinicaltrials.gov