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The Effect of Electroacustimulation on Postoperative Nausea, Vomiting and Pain in Outpatient Plastic Surgery Patients

Not Applicable
Completed
Conditions
Postoperative Nausea and Vomiting
Interventions
Device: Electroacustimulation
Registration Number
NCT00941005
Lead Sponsor
University of Wisconsin, Madison
Brief 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
122
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
ElectroacustimulationElectroacustimulationReceived electroacustimulation at the wrist using a small, battery-powered electroacustimulation device.
ControlElectroacustimulationReceived a device that was not turned on.
Primary Outcome Measures
NameTimeMethod
Phone Survey of Nausea / Vomiting Symptoms 24 Hours Post-op24 hours post-op

Phone survey of nausea/vomiting symptoms was administered on postoperative day 1. The survey consists of 8 questions, including: 1) a query about whether or not participant has experienced nausea since returning home; 2) rate nausea severity on a scale of 1-10 (where 10 is the most severe); 3) a query about satisfaction of nausea control; 4) a question asking if they would use the same post-op nausea treatment again; 5) a query about what activities the participant has been unable to do since surgery; 6) whether or not the participant has taken prescription medicine for treatment of nausea since returning home; 7) whether or not participant has taken prescription medicine for treatment of pain since returning home; and 8) if yes for 6-7, which medications.

Post-operative Nausea Scores24 hours

Nausea is scored on a scale of 1-10 where 1 is least nauseated and 10 is severely nauseated. Nausea scores will be collected 30, 60, and 120 minutes after surgery.

Incidence of Post-operative Emetic Events24 hours
Number of Participants With Post-operative Need for Rescue Medications24 hours
Time to Participant Discharge24 hours
Secondary Outcome Measures
NameTimeMethod
Number of Participants Who Took Pain Medicine in the First 24 Hours Post-op24 hours post-op

Phone survey of post-op pain medication usage was administered on postoperative day 1.

Postoperative Pain Scores24 hours

Participants will evaluate their postoperative pain score on a scale of 1-10 where 1 is the least pain and 10 is the most severe pain. Pain scores will be evaluated at 30, 60, and 120 minutes postop.

Trial Locations

Locations (1)

Transformations Surgery Center

🇺🇸

Middleton, Wisconsin, United States

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