Reletex Versus Standard of Care Therapy for Post-Operative Nausea Control in Patients Undergoing Foregut Surgery
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Nausea and Vomiting Post-foregut Surgery |
Device: Reletex |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Median Nerve Acustimulation Plus Medical Anti-emetic Therapy for Control Post-operative Nausea in Patients Undergoing Foregut Surgery: A Randomized Control Trial |
- Comparison of postoperative nausea and vomiting scores between groups treated with a ReletexTM device and those without the device. [ Time Frame: One week ] [ Designated as safety issue: No ]
- Quantify the amounts of phenergan used between the two groups. [ Time Frame: one week ] [ Designated as safety issue: No ]
| Enrollment: | 100 |
| Study Start Date: | August 2011 |
| Study Completion Date: | August 2012 |
| Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Reletex
Reletex plus scheduled ondansetron and phenergan prn
|
Device: Reletex
Neurostimulation device for prevention/treatment of post-operative nausea and vomiting.
|
|
Active Comparator: Control
Scheduled ondansetron plus phenergan prn
|
Device: Reletex
Neurostimulation device for prevention/treatment of post-operative nausea and vomiting.
|
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Kyle A Perry, Assistant Professor General Surgery 614-293-5815, The Ohio State University |
| ClinicalTrials.gov Identifier: | NCT01510379 History of Changes |
| Other Study ID Numbers: | 2011H0236 |
| Study First Received: | January 5, 2012 |
| Last Updated: | December 4, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Ohio State University:
|
nausea vomiting post-operative foregut surgery |
Additional relevant MeSH terms:
|
Nausea Vomiting Postoperative Nausea and Vomiting Signs and Symptoms, Digestive |
Signs and Symptoms Postoperative Complications Pathologic Processes |
ClinicalTrials.gov processed this record on May 22, 2013