N/A
N=122
The Effect of Electroacustimulation on Postoperative Nausea, Vomiting and Pain in Outpatient Plastic Surgery Patients
Postoperative Nausea and Vomiting
Bottom Line
View on ClinicalTrials.gov: NCT00941005 ↗Enrolled (actual)
122
Serious AEs
—
Results posted
Aug 2020
Primary outcome: Primary: Post-operative Nausea Scores — NA; NA; NA; NA participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Electroacustimulation (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Wisconsin, Madison
- Primary completion
- Dec 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Post-operative Nausea Scores |
NA; NA; NA; NA; NA; NA | — |
| PRIMARY Incidence of Post-operative Emetic Events |
0; 0 | — |
| PRIMARY Number of Participants With Post-operative Need for Rescue Medications |
NA; NA | — |
| PRIMARY Time to Participant Discharge |
NA; NA | — |
| PRIMARY Phone Survey of Nausea / Vomiting Symptoms 24 Hours Post-op |
NA; NA | — |
| SECONDARY Postoperative Pain Scores |
NA; NA; NA; NA; NA; NA | — |
| SECONDARY Number of Participants Who Took Pain Medicine in the First 24 Hours Post-op |
NA; NA | — |
Summary
Introduction: Current rates of postoperative nausea and vomiting (PONV) experienced by outpatient surgery patients are as high as 20-30%. Electroacustimulation (EAS) therapy has been demonstrated to be effective in controlling these symptoms, but trials identifying their efficacy in the outpatient surgery population are lacking. This study integrates conventional pharmacotherapy with alternative medicine in prevention of PONV.
Materials and Methods: One hundred twenty two patients undergoing surgery procedures at an outpatient surgery center were randomized to two treatment arms. The first arm was standardized pharmacologic PONV prevention typical for patients undergoing outpatient surgery, while the second arm employed the use of ReliefBand, an FDA-approved electroacustimulation (EAS) device with pharmacologic treatment to relieve symptoms of PONV and pain. EAS is a derivative of acupuncture therapy that uses a small electrical current to stimulate acupuncture points on the human body and is thought to relieve nausea, vomiting and pain. Outcomes measured were post-op questionnaires evaluating pain and nausea symptoms, emetic events, the need for rescue medications and the time to discharge.
Eligibility Criteria
Inclusion Criteria
- undergoing surgery at the University of Wisconsin outpatient surgery center
Exclusion Criteria
- pregnancy
- currently experiencing menstrual symptoms
- cardiac pacemaker
- previous experience with acupuncture therapy
- pharmacologic treatment for nausea or vomiting in the 24 hours prior to surgery
Data sourced from ClinicalTrials.gov (NCT00941005). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.