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

Nausea and Vomiting Post-foregut Surgery Clinical Trial

— Reletex  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01510379
• Other study ID #: 2011H0236
• Status: Completed
• Phase: N/A
• First received: January 5, 2012
• Last updated: February 24, 2014
• Start date: August 2011
• Est. completion date: August 2012

Study information

• Verified date: January 2014
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Nausea
• Nausea and Vomiting Post-foregut Surgery

Intervention

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

Drug:
• IV ondansetron 4 mg q 6 hours for a total of 4 doses

• IV promethazine 25 mg q 6 hours prn

• Elixir promethazine 25 mg q 6 hours prn after discharge

Locations

Country	Name	City	State
United States	The Ohio State University Medical Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Kyle A Perry

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Quantify the Amounts of Phenergan Used Between the Two Groups.		one week	No