N/A
N=184
Intraoperative Acupoint Stimulation to Prevent Post-Operative Nausea and Vomiting (PONV)
Post-Operative Nausea and Vomiting · Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02473042 ↗Enrolled (actual)
184
Serious AEs
0.0%
Results posted
Dec 2025
Primary outcome: Primary: Efficacy of Intervention to Prevent Post-Operative Nausea and Vomiting (PONV) — 19; 12; 67; 71 Participants — p=0.2787
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Electrical Stimulation (Procedure); Zofran (Drug); Dexamethasone (Drug); Phenergan (Drug); Pepcid (Drug); Questionnaire (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Nov 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Efficacy of Intervention to Prevent Post-Operative Nausea and Vomiting (PONV) |
19; 12; 67; 71; 0; 3 | 0.2787 |
| SECONDARY Feasibility of Conducting Study |
233; 188; 86 | — |
| SECONDARY Efficacy of Intervention to Prevent Need for Rescue Anti-emetics |
45; 54; 14; 11; 45; 54 | — |
| SECONDARY Satisfaction |
8.92; 9.25 | 0.8252 |
| SECONDARY Efficacy of Intervention to Result in Decreased PACU Length-of-stay |
120; 119.46 | 0.8277 |
| SECONDARY Expectancy |
13; 8; 14; 18; 45; 37 | 0.3908 |
| SECONDARY Expectancy and Response to P6 Stimulation |
6; 15; 6; 25; 9; 72 | 0.2742 |
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.
Eligibility Criteria
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
- 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
- Current acknowledged use of any illicit drugs, medical marijuana (including Marinol), or evidence of alcohol abuse as defined by The American Psychiatric Association criteria. This includes patients who are currently in the recovery process.
- Pregnancy as this would alter anesthesia plan
- Bowel obstruction
- Surgery that would not allow access to at least one P6 site.
Data sourced from ClinicalTrials.gov (NCT02473042). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.