Intraoperative Acupoint Stimulation to Prevent Post-Operative Nausea and Vomiting (PONV) (NCT02473042) | Clinical Trial Compass
CompletedNot Applicable
Intraoperative Acupoint Stimulation to Prevent Post-Operative Nausea and Vomiting (PONV)
United States188 participantsStarted 2016-03-01
Plain-language summary
The goal of this clinical research study is to learn if light electrical stimulation to the wrist area during surgery is feasible in women having breast surgery.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Adults at least 18 years of age
. Female gender
. History of patient reported PONV, CINV or motion sickness
. Patients scheduled for Breast Surgery
. Sign an informed consent indicating they are aware of the investigational nature of this study.
Exclusion criteria
. Patients scheduled for paravertebral block
. Upper extremity deformity contralateral to the site of disease that could interfere with accurate point location or alter the energy pathway as defined by traditional acupuncture theory
. Local skin infections at or near the acustimulation site
. Pre-existing nausea and vomiting, defined as nausea or vomiting requiring pharmacological treatment greater than 3 times in the week preceding screening
. History of CVA or other central nervous system disorder resulting in residual weakness or paresis of extremity contralateral to the site of disease
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Efficacy of Intervention to Prevent Post-Operative Nausea and Vomiting (PONV)
Timeframe: During stay in post-operative anesthesia care unit, until discharge, an average of 1 day
. Grade III or IV upper extremity peripheral neuropathy
. Cardiac pacemakers. Patients involved in this protocol will receive electrical stimulation. For safety reasons, electrical stimulation should be avoided in patients with pacemakers
. Metal implants for the treatment extremity. For safety reasons, use of electrical stimulation should be avoided