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.

Conditions

• Bariatric Sleeve Gastrectomy
• Postoperative Nausea and Vomiting

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Wearable Transcutaneous electrical Nerve Stimulation unit to mitigate postoperative nausea and vomiting (PONV) in the Bariatric Surgical Patient — DEVICE
  Use 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. — DEVICE
  The 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.

Study Details

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

Key Dates

Start date

Nov 4, 2025

Status verified

Jun 2026

Primary completion

Jul 31, 2027

Completion

Jul 31, 2027

Study Design

Enrollment

100 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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.

Primary Outcome Measure

Post operative nausea and vomiting (PONV) incidents utilizing the PONV impact scale in placebo/sham vs active group. [ Time Frame: This will be assessed over the first 24 hours postoperatively. ]

Central Contacts

• Donna L Post, Bariatric Coordinator/Nurse Navigator, BSN
  609-423-8102
  [email protected]
• Lisa Dobruskin, MD Medical Director Penn Med Princeton Bariatrics, MD
  609-785-5870
  [email protected]

Locations (1)

Find similar trials in Plainsboro, NJ

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