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

This study has been completed.
Sponsor:
Information provided by:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00941005
First received: July 15, 2009
Last updated: July 16, 2009
Last verified: July 2009
  Purpose

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.


Condition Intervention
Postoperative Nausea and Vomiting
Device: Electroacustimulation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: The Effect of Electroacustimulation on Postoperative Nausea, Vomiting and Pain in Outpatient Plastic Surgery Patients: A Prospective, Randomized, Blinded Clinical Trial

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Post-operative questionnaires evaluating nausea symptoms, emetic events, the need for rescue medications and the time to discharge. Also, a phone survey of nausea/vomiting symptoms was administered on postoperative day 1. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Postoperative questionnaires evaluating pain symptoms immediately after surgery and on postoperative day 1. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Enrollment: 122
Study Start Date: January 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Electroacustimulation
Received electroacustimulation at the wrist using a small, battery-powered electroacustimulation device.
Device: Electroacustimulation
Electroacustimulation (EAS) is a derivative form of acupuncture therapy where a small current of electricity instead of a needle is used to stimulate an acupoint on the human body in an effort to create therapeutic effects.
Other Name: ReliefBand (Aeromedix, Jackson, WY)
Sham Comparator: Control
Received a device that was not turned on.
Device: Electroacustimulation
Electroacustimulation (EAS) is a derivative form of acupuncture therapy where a small current of electricity instead of a needle is used to stimulate an acupoint on the human body in an effort to create therapeutic effects.
Other Name: ReliefBand (Aeromedix, Jackson, WY)

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00941005

Locations
United States, Wisconsin
Transformations Surgery Center
Middleton, Wisconsin, United States, 53719
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Karol A Gutowski, MD NorthShore University HealthSystem
  More Information

Publications:
Responsible Party: Jeffrey D. Larson, MD, University of Wisconsin Hospitals and Clinics
ClinicalTrials.gov Identifier: NCT00941005     History of Changes
Other Study ID Numbers: H-2007-0100
Study First Received: July 15, 2009
Last Updated: July 16, 2009
Health Authority: United States: Institutional Review Board

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 April 14, 2014