Overnight Use of Electroacustimulation on Postoperative Nausea and Vomiting in the Outpatient Surgery Population

This study has been withdrawn prior to enrollment.
(The study was closed prior to enrollment of any subjects. No subjects were enrolled in this study.)
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01394536
First received: June 28, 2011
Last updated: October 16, 2012
Last verified: October 2012

June 28, 2011
October 16, 2012
June 2011
May 2012   (final data collection date for primary outcome measure)
Measure of post-operative nausea and vomiting scores [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
The primary outcome will be post-operative nausea and vomiting scores on a scale of 1-10 based on surveys which will be performed at 30m, 60m, 120m, and 24h post-op.
Same as current
Complete list of historical versions of study NCT01394536 on ClinicalTrials.gov Archive Site
  • Measure of amount of rescue nausea medications required [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    The amount of rescue nausea medications required by the patients, time to discharge, subjective pain assessment and the impact of their symptoms on the activities of daily living since being discharged from the surgery center based on survey, and amount of narcotic received.
  • Amount of time spent in recovery post-operatively [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    This project would also aim to reduce the amount of time patients spend in recovery post-operatively, reduce hospital admissions secondary to persistent nausea and vomiting, and educate students and trainees about alternative methods of treating and preventing postoperative nausea and vomiting.
Same as current
Not Provided
Not Provided
 
Overnight Use of Electroacustimulation on Postoperative Nausea and Vomiting in the Outpatient Surgery Population
The Effect of Overnight Use of Electroacustimulation on Postoperative Nausea and Vomiting in the Outpatient Surgery Population

Postoperative nausea and vomiting after outpatient surgery are significant sources of patient dissatisfaction. The prevention of postoperative nausea and vomiting (PONV) should be equally as important as prevention of pain because both are large sources of patient dissatisfaction and can necessitate admission after routine outpatient procedures.

None of the currently available pharmacological interventions are able to totally abolish PONV. The use of electroacustimulation is a useful adjunct in prevention of PONV, but has yet to be studied when the patient takes the device home with them after leaving an outpatient facility.

The goal of this project is to perform a pilot study to determine if sending patients home with the electroacustimulation device will decrease their PONV and subsequently increase their overall satisfaction.

The primary outcome will be post-operative nausea and vomiting scores on a scale of 1-10 based on surveys which will be performed at 30m, 60m, 120m, and 24h post-op.

Secondary outcomes will be the amount of rescue nausea medications required by the patients, time to discharge, subjective pain assessment and the impact of their symptoms on the activities of daily living since being discharged from the surgery center based on survey, and amount of narcotic received.

This project would also aim to reduce the amount of time patients spend in recovery post-operatively, reduce hospital admissions secondary to persistent nausea and vomiting, and educate students and trainees about alternative methods of treating and preventing postoperative nausea and vomiting.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Post-operative Nausea and Vomiting
  • Device: Battery-operated electroacustimulation device (Inactive)
    In the sham arm, this device will not be turned on. The device to be used is the ReliefBand (Aeromedix, Jackson, Wy), an FDA-approved, reusable, battery-operated electroacustimulation device. The ReilefBand is a portable battery powered (lithium coin cells) device that is worn on the wrist like a watch. Two electrodes contact the skin with the aid of the application of electroconductive gel, and an electrical current of 25 mHz is transmitted through the skin. The device is applied at the Neiguan (P6) point, which is located on the inside of the wrist and is thought, in traditional Chinese medicine, to relieve nausea and vomiting (NV).
    Other Name: ReliefBand
  • Device: Battery-operated electroacustimulation device (Active)
    The device to be used is the ReliefBand (Aeromedix, Jackson, Wy), an FDA-approved, reusable, battery-operated electroacustimulation device. The ReilefBand is a portable battery powered (lithium coin cells) device that is worn on the wrist like a watch. Two electrodes contact the skin with the aid of the application of electroconductive gel, and an electrical current of 25 mHz is transmitted through the skin. The device is applied at the Neiguan (P6) point, which is located on the inside of the wrist and is thought, in traditional Chinese medicine, to relieve nausea and vomiting (NV).
    Other Name: ReliefBand
  • Sham Comparator: 1
    "Sham" device - an EAS band placed over the P6 acupoint that will be turned off (inactive).
    Intervention: Device: Battery-operated electroacustimulation device (Inactive)
  • Active Comparator: 2
    The second arm will use the ReliefBand (Aeromedix, Jackson, WY), an FDA-approved, reusable, battery-operated electroacustimulation device.
    Intervention: Device: Battery-operated electroacustimulation device (Active)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
Not Provided
May 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

• scheduled for outpatient surgery procedure under general anesthesia

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
Both
18 Years to 89 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01394536
H-2010-0063
No
University of Wisconsin, Madison
University of Wisconsin, Madison
Not Provided
Principal Investigator: Benjamin Marcus, MD University of Wisconsin, Madison
University of Wisconsin, Madison
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP