Intraoperative electrical stimulation of the acupoint P6 to prevent post-operative nausea and vomiting in women undergoing breast surgery

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.

Disease Group: Breast

Treatment Agent: Acupuncture

Treatment Location: Only at MDACC

Sponsor: UTMDACC Division of Anesthesiology and Critical Care Career Development Award

The proposed two-arm, randomized, double-blind (patient and assessor), controlled feasibility study will determine the feasibility and initial efficacy of anesthesiologist-provided intraoperative neuromuscular blockade monitor (NMBM) electrical stimulation of the acupoint pericardium 6 (P6) combined with prophylactic anti-emetics versus pharmacological prophylaxis alone in women at high-risk for post-operative nausea and vomiting (PONV) undergoing breast surgery. This study will provide preliminary evidence of efficacy to inform the design of a larger multi-institutional trial. We will also explore predictors of response to P6 stimulation including genetic polymorphisms and expectancy. PRIMARY AIM: 1. Determine the feasibility of anesthesiologist-provided intraoperative NMBM electrical stimulation of P6 combined with prophylactic anti-emetics in women at high-risk for PONV undergoing breast surgery SECONDARY AIMS: 1. Examine the efficacy of electrical stimulation of P6 combined with prophylactic anti-emetics versus pharmacological prophylaxis alone in preventing the incidence and severity of PONV following breast surgery in patients at high-risk for PONV. 2. Examine the effects of intra-operative NMBM stimulation of P6 results on need for rescue anti-emetics compared to the control group. 3. Examine group differences in post-operative patient satisfaction with PONV management. 4. Explore if intra-operative NMBM stimulation of P6 results in decreased PACU length-of-stay and decreased rate of unplanned hospital admission 5. Explore the associations between genetic polymorphisms in COMT, 5HT3, OPRM1, and DRD2 and response to P6 stimulation. 6. Explore the associations between expectancy and response to P6 stimulation.

IRB Review and Approval Date: 02/29/2016

Recruitment Status: Open

Projected Accrual: N/A

1) Adults at least 18 years of age
2) Female gender
3) History of patient reported PONV, CINV or motion sickness
4) Patients scheduled for Breast Surgery
5) Sign an informed consent indicating they are aware of the investigational nature of this study.

1) Patients scheduled for paravertebral block
2) 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
3) Local skin infections at or near the acustimulation site
4) Pre-existing nausea and vomiting, defined as nausea or vomiting requiring pharmacological treatment greater than 3 times in the week preceding screening
5) History of CVA or other central nervous system disorder resulting in residual weakness or paresis of extremity contralateral to the site of disease
6) Grade III or IV upper extremity peripheral neuropathy
7) Cardiac pacemakers. Patients involved in this protocol will receive electrical stimulation. For safety reasons, electrical stimulation should be avoided in patients with pacemakers
8) Metal implants for the treatment extremity. For safety reasons, use of electrical stimulation should be avoided
9) 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.
10) Pregnancy as this would alter anesthesia plan
11) Bowel obstruction
12) Surgery that would not allow access to at least one P6 site.

713-745-5089

Phone Number: 1-877-MDA-6789

clinicaltrials.gov NCT No: NCT02473042