Intraoperative Acupoint Stimulation to Prevent Post-Operative Nausea and Vomiting (PONV)

NCT02473042 | Completed Results DMC FDA Drug

• 2 other identifiers: 2015-0170NCI-2015-01519
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Post-Operative Nausea and Vomiting; Breast Cancer

Keywords

Post-operative nausea and vomiting; PONV; Breast cancer; Neuromuscular blockade monitor; NMBM; Breast cancer surgery; Prophylactic anti-emetics; Electrical stimulation; Zofran; Ondansetron; Dexamethasone; Decadron; Phenergan; Promethazine; Phenazine; Phencen; Prometh; Prorex; V-Gan; Pepcid; Famotidine; Questionnaire; Survey

Outcome Measures

Primary Outcomes (1)

• Efficacy of Intervention to Prevent Post-Operative Nausea and Vomiting (PONV)

  Examine the efficacy of electrical stimulation of P6 combined with prophylactic anti-emetics versus pharmacological prophylaxis alone in preventing the incidence of PONV following breast surgery in patients at high-risk for PONV Complete control is defined as "No nausea≥3 \& No vomiting \& No use of anti-emetic during PACU stay"

  During stay in post-operative anesthesia care unit, until discharge, an average of 1 day

Secondary Outcomes (6)

• Feasibility of Conducting Study

  At study consent and at PACU discharge

• Efficacy of Intervention to Prevent Need for Rescue Anti-emetics

  During stay in post-operative anesthesia care unit, until discharge, an average of 1 day

• Satisfaction

  At discharge from post-operative anesthesia care unit

• Efficacy of Intervention to Result in Decreased PACU Length-of-stay

  During stay in post-operative anesthesia care unit, until discharge, an average of 1 day

• Expectancy

  Baseline

Study Arms (2)

Electrical Stimulation + Standard of Care Antiemetics

EXPERIMENTAL

Participants receive light electrical stimulation to the wrist area during surgery. Participants also receive standard of care drugs to reduce post-operative nausea and vomiting (PONV). Questionnaire completed about participant's pre-treatment expectations and their nausea about 15 minutes after they wake up after surgery, then every 30 minutes until they leave the clinic.

Procedure: Electrical Stimulation; Drug: Zofran; Drug: Dexamethasone; Drug: Phenergan; Drug: Pepcid; Behavioral: Questionnaire

Standard of Care Antiemetics

ACTIVE COMPARATOR

Participants receive standard of care drugs to reduce post-operative nausea and vomiting (PONV). Questionnaire completed about participant's pre-treatment expectations and their nausea about 15 minutes after they wake up after surgery, then every 30 minutes until they leave the clinic.

Drug: Zofran; Drug: Dexamethasone; Drug: Phenergan; Drug: Pepcid; Behavioral: Questionnaire

Interventions

Electrical Stimulation PROCEDURE

Electrical stimulation to the wrist initiated at 1mHz, 1 pulse/second using two leads on a nerve stimulator. Stimulation continued throughout the breast surgery.

Electrical Stimulation + Standard of Care Antiemetics

Zofran DRUG

4 mg by vein for 1 dose.

Also known as: Ondansetron

Electrical Stimulation + Standard of Care Antiemetics; Standard of Care Antiemetics

Dexamethasone DRUG

10 mg by vein for 1 dose.

Also known as: Decadron

Electrical Stimulation + Standard of Care Antiemetics; Standard of Care Antiemetics

Phenergan DRUG

6.25 mg by vein for 1 dose.

Also known as: Promethazine, Phenazine, Phencen, Prometh, Prorex, V-Gan

Electrical Stimulation + Standard of Care Antiemetics; Standard of Care Antiemetics

Pepcid DRUG

10 mg by vein for 1 dose.

Also known as: Famotidine

Electrical Stimulation + Standard of Care Antiemetics; Standard of Care Antiemetics

Questionnaire BEHAVIORAL

Questionnaire completed about 15 minutes after participant wakes up after surgery, then every 30 minutes until they leave the clinic. It should take about 2 - 3 minutes to complete the questionnaire.

Also known as: Survey

Electrical Stimulation + Standard of Care Antiemetics; Standard of Care Antiemetics

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Vomiting; Breast Neoplasms; Postoperative Nausea and Vomiting

Interventions

Electric Stimulation; Ondansetron; Dexamethasone; Calcium Dobesilate; Promethazine; phenazine; Diphenhydramine; Famotidine; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Postoperative Complications; Pathologic Processes; Nausea

Intervention Hierarchy (Ancestors)

Physical Stimulation; Investigative Techniques; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Propylamines; Amines; Phenothiazines; Ethylamines; Benzhydryl Compounds; Thiazoles; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Results Point of Contact

• Title: Alicia Kowalski, MD
• Organization: The University of Texas MD Anderson Cancer Center

amkowalsk@mdanderson.org

(713) 563-5614

Study Officials

• Alicia M. Kowalski, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2015
• First Posted: June 16, 2015
• Study Start: March 1, 2016
• Primary Completion: November 26, 2024
• Study Completion: November 26, 2024
• Last Updated: December 5, 2025
• Results First Posted: December 5, 2025

Record last verified: 2025-12

Locations

US (1)