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

University of Wisconsin (UW)

Status: Withdrawn

Conditions: Post-operative Nausea and Vomiting

Treatments: Device: Battery-operated electroacustimulation device (Active); Device: Battery-operated electroacustimulation device (Inactive)

Study type: Interventional

Funder types: Other

Identifiers

NCT01394536

H-2010-0063

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

1

Sham Comparator group

Description:

"Sham" device - an EAS band placed over the P6 acupoint that will be turned off (inactive).

Treatment:

Device: Battery-operated electroacustimulation device (Inactive)

2

Active Comparator group

Description:

The second arm will use the ReliefBand (Aeromedix, Jackson, WY), an FDA-approved, reusable, battery-operated electroacustimulation device.

Treatment:

Device: Battery-operated electroacustimulation device (Active)