Nausea and Vomiting Post-foregut Surgery Clinical Trial
Official title:
Median Nerve Acustimulation Plus Medical Anti-emetic Therapy for Control Post-operative Nausea in Patients Undergoing Foregut Surgery: A Randomized Control Trial
The effect a ReletexTM device has on postoperative nausea and vomiting when used with
ondansetron after foregut surgery will be studied. A ReletexTM device is a FDA approved
wristwatch-like device that painlessly stimulates a nerve in the wrist and has been shown to
decrease nausea and vomiting. The investigators will randomize 100 patients who are having a
fundoplication for either gastroesophageal reflux disease (GERD), paraesophageal hernia, or
Heller Myotomy for achalasia into two groups. A control group will receive scheduled
ondansetron for prevention and treatment of postoperative nausea and vomiting and phenergan
as needed. The treatment group will wear a ReletexTM wrist band after surgery for 7 days.
These patients will also get scheduled ondansetron and phenergan as needed, like the control
group. The investigators will compare nausea, retching, and the amount of supplemental
nausea medication used between the two groups. The patients will be provided a diary to
document their nausea, retching, and medication use.
The hypothesis of this study is that use of the ReletexTM device will reduce post-operative
nausea and vomiting, and will reduce post-operative use of anti-emetic medications in
patients who have undergone foregut surgery.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention