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.

Study Overview

• Status: Withdrawn
• Conditions: Post-operative Nausea and Vomiting
• Intervention / Treatment: Device: Battery-operated electroacustimulation device (Inactive); Device: Battery-operated electroacustimulation device (Active)

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin-Madison

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: 1; "Sham" device - an EAS band placed over the P6 acupoint that will be turned off (inactive).	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 Names: ReliefBand
Active Comparator: 2; The second arm will use the ReliefBand (Aeromedix, Jackson, WY), an FDA-approved, reusable, battery-operated electroacustimulation device.	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 Names: ReliefBand

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 hours
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.	24 hours

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Investigators: Principal Investigator: Benjamin Marcus, MD, University of Wisconsin, Madison

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: June 28, 2011
• First Submitted That Met QC Criteria: July 12, 2011
• First Posted (Estimate): July 14, 2011

Study Record Updates

• Last Update Posted (Estimate): October 17, 2012
• Last Update Submitted That Met QC Criteria: October 16, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: nausea; Post-operative; vomiting; post-op
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Signs and Symptoms, Digestive; Nausea; Vomiting; Postoperative Nausea and Vomiting
• Other Study ID Numbers: H-2010-0063