Overnight Use of Electroacustimulation on Postoperative Nausea and Vomiting in the Outpatient Surgery Population
Primary Purpose
Post-operative Nausea and Vomiting
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Battery-operated electroacustimulation device (Inactive)
Battery-operated electroacustimulation device (Active)
Sponsored by
About this trial
This is an interventional prevention trial for Post-operative Nausea and Vomiting focused on measuring Post-operative, post-op, nausea, vomiting
Eligibility Criteria
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
Sites / Locations
- University of Wisconsin-Madison
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Active Comparator
Arm Label
1
2
Arm Description
"Sham" device - an EAS band placed over the P6 acupoint that will be turned off (inactive).
The second arm will use the ReliefBand (Aeromedix, Jackson, WY), an FDA-approved, reusable, battery-operated electroacustimulation device.
Outcomes
Primary Outcome Measures
Measure of post-operative nausea and vomiting scores
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 Outcome Measures
Measure of amount of rescue nausea medications required
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
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.
Full Information
NCT ID
NCT01394536
First Posted
June 28, 2011
Last Updated
October 16, 2012
Sponsor
University of Wisconsin, Madison
1. Study Identification
Unique Protocol Identification Number
NCT01394536
Brief Title
Overnight Use of Electroacustimulation on Postoperative Nausea and Vomiting in the Outpatient Surgery Population
Official Title
The Effect of Overnight Use of Electroacustimulation on Postoperative Nausea and Vomiting in the Outpatient Surgery Population
Study Type
Interventional
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Withdrawn
Why Stopped
The study was closed prior to enrollment of any subjects. No subjects were enrolled in this study.
Study Start Date
June 2011 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-operative Nausea and Vomiting
Keywords
Post-operative, post-op, nausea, vomiting
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Sham Comparator
Arm Description
"Sham" device - an EAS band placed over the P6 acupoint that will be turned off (inactive).
Arm Title
2
Arm Type
Active Comparator
Arm Description
The second arm will use the ReliefBand (Aeromedix, Jackson, WY), an FDA-approved, reusable, battery-operated electroacustimulation device.
Intervention Type
Device
Intervention Name(s)
Battery-operated electroacustimulation device (Inactive)
Other Intervention Name(s)
ReliefBand
Intervention Description
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).
Intervention Type
Device
Intervention Name(s)
Battery-operated electroacustimulation device (Active)
Other Intervention Name(s)
ReliefBand
Intervention Description
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).
Primary Outcome Measure Information:
Title
Measure of post-operative nausea and vomiting scores
Description
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.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Measure of amount of rescue nausea medications required
Description
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.
Time Frame
24 hours
Title
Amount of time spent in recovery post-operatively
Description
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.
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin Marcus, MD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin-Madison
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
12. IPD Sharing Statement
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Overnight Use of Electroacustimulation on Postoperative Nausea and Vomiting in the Outpatient Surgery Population
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