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Neuromuscular Electrical Stimulation of Acupoint P6 in Preventing Nausea and Vomiting after Surgery in Patients Undergoing Breast Surgery

Trial Status: Closed to Accrual

This randomized clinical trial studies how well neuromuscular electrical stimulation of acupoint pericardium (P) 6 works in preventing nausea and vomiting after surgery in female patients undergoing breast surgery. Acupoint P6 is a specific spot on the wrist area where an electrical stimulator may be inserted to control pain and other symptoms. Giving neuromuscular electrical stimulation of acupoint P6 before and during surgery may prevent and treat nausea and vomiting following surgery in female patients undergoing breast surgery.

Inclusion Criteria

  • History of patient reported PONV, chemotherapy-induced nausea and vomiting (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 cerebral vascular accident (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 in avoided in patients with pacemakers.
  • Metal implants for the treatment extremity. For safety reasons, electrical stimulation should in 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

Texas

Houston
M D Anderson Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Alicia M Kowalski
Phone: 713-745-5089

PRIMARY OBJECTIVE:

I. Examine the efficacy of electrical stimulation of P6 combined with prophylactic anti-emetics versus pharmacological prophylaxis alone in preventing the incidence of post-operative nausea and vomiting (PONV) following breast surgery in patients at high-risk for PONV.

SECONDARY OBJECTIVES:

I. Determine the study feasibility and effects on severity of PONV of anesthesiologist-provided intraoperative neuromuscular blockade monitor (NMBM) electrical stimulation of P6 combined with prophylactic anti-emetics in women at high-risk for PONV undergoing breast surgery.

II. Examine the effects of intra-operative NMBM stimulation of P6 on need for rescue anti-emetics compared to the control group.

III. Examine group differences in post-operative patient satisfaction with PONV management.

IV. Explore if intra-operative NMBM stimulation of P6 results in decreased post-anesthesia care unit (PACU) length-of-stay and decreased rate of unplanned hospital admission.

V. Explore the associations between genetic polymorphisms in COMT, 5-hydroxytryptamine type 3 (5HT3), OPRM1, and DRD2 and response to P6 stimulation.

VI. Explore the associations between expectancy and response to P6 stimulation.

OUTLINE: Patients are randomized to 1 of 2 treatment groups.

GROUP I. Patients undergo neuromuscular electrical stimulation after induction, before incision, and continuing throughout the surgery. Patients also receive standard of care prophylactic antiemetics consisting of ondansetron hydrochloride intravenously (IV), dexamethasone IV, promethazine hydrochloride IV, and famotidine.

GROUP II: Patients receive standard of care prophylactic antiemetics as in Group I.

Trial Phase Phase NA

Trial Type Supportive care

Lead Organization
M D Anderson Cancer Center

Principal Investigator
Alicia M Kowalski

  • Primary ID 2015-0170
  • Secondary IDs NCI-2015-01519
  • Clinicaltrials.gov ID NCT02473042