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Completed

NCT Number: NCT01510379

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

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Reletex

Device

Neurostimulation device for prevention/treatment of post-operative nausea and vomiting, Reletex arm.

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

Primary outcomes

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

    Time frame: 24 hours

    Post-operative Nausea and Vomiting (PONV) Likert scale, 0-10 (0=no PONV, 10=worst PONV).

Secondary outcomes

  1. Quantify the Amounts of Phenergan Used Between the Two Groups.

    Time frame: one week

Sponsors and collaborators

Lead sponsor

Kyle A Perry

Other

Registry information

Official study title

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

Acronym: Reletex

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jan 16, 2012
Registry last updated
Mar 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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