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

Study Overview
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Brief Summary
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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.

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

Conditions
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Nausea and Vomiting Post-foregut Surgery

Intervention / Treatment
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* Device: Reletex
* Drug: 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Reletex<br>Reletex plus scheduled IV ondansetron 4 mg q 6 hours for a total of 4 doses. Breakthrough nausea will be treated using IV promethazine 25 mg q 6 hours prn during the hospital stay and in elixir at the same dose and frequency after discharge. | Device: Reletex<br>* Neurostimulation device for prevention/treatment of post-operative nausea and vomiting, Reletex arm.<br>Drug: IV ondansetron 4 mg q 6 hours for a total of 4 doses<br> <br> Drug: IV promethazine 25 mg q 6 hours prn<br> <br> Drug: Elixir promethazine 25 mg q 6 hours prn after discharge<br> <br> |
| Other: Control<br>Scheduled IV ondansetron 4 mg q 6 hours for a total of 4 doses. Breakthrough nausea will be treated using IV promethazine 25 mg q 6 hours prn during the hospital stay and in elixir at the same dose and frequency after discharge. | Device: Reletex<br>* Neurostimulation device for prevention/treatment of post-operative nausea and vomiting, Reletex arm.<br>Drug: IV ondansetron 4 mg q 6 hours for a total of 4 doses<br> <br> Drug: IV promethazine 25 mg q 6 hours prn<br> <br> Drug: Elixir promethazine 25 mg q 6 hours prn after discharge<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of Postoperative Nausea and Vomiting Scores Between Groups Treated With a ReletexTM Device and Those Without the Device. | Post-operative Nausea and Vomiting (PONV) Likert scale, 0-10 (0=no PONV, 10=worst PONV). | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantify the Amounts of Phenergan Used Between the Two Groups. |  | one week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nausea, vomiting, post-operative, foregut surgery