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Reletex Versus Standard of Care Therapy for Post-Operative Nausea Control in Patients Undergoing Foregut Surgery

Information source: Ohio State University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Nausea and Vomiting Post-foregut Surgery

Intervention: Reletex (Device); IV ondansetron 4 mg q 6 hours for a total of 4 doses (Drug); IV promethazine 25 mg q 6 hours prn (Drug); Elixir promethazine 25 mg q 6 hours prn after discharge (Drug)

Phase: N/A

Status: Completed

Sponsored by: Kyle A Perry

Official(s) and/or principal investigator(s):
Kyle Perry, MD, Principal Investigator, Affiliation: Ohio State University


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.

Clinical Details

Official title: Median Nerve Acustimulation Plus Medical Anti-emetic Therapy for Control Post-operative Nausea in Patients Undergoing Foregut Surgery: A Randomized Control Trial

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: Comparison of Postoperative Nausea and Vomiting Scores Between Groups Treated With a ReletexTM Device and Those Without the Device.

Secondary outcome: Quantify the Amounts of Phenergan Used Between the Two Groups.


Minimum age: 18 Years. Maximum age: 85 Years. Gender(s): Both.


Inclusion Criteria:

- Age 18-85

- Planned fundoplication

- Willingness to comply with randomization and follow-up protocol

- English speaking

Exclusion Criteria:

- < 18 years of age or > 85

- Chronic nausea requiring medical treatment

- Planned concomitant procedures

- Pacemaker or automatic internal cardiac defibrillator

Locations and Contacts

The Ohio State University Medical Center, Columbus, Ohio 43210, United States
Additional Information

Starting date: August 2011
Last updated: February 24, 2014

Page last updated: August 23, 2015

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