Clinical trial NCT02473042: Intraoperative Acupoint Stimulation to Prevent Post-Operative Nausea and Vomiting (PONV)
Official title: Intraoperative Electrical Stimulation of the Acupoint P6 to Prevent Post-Operative Nausea and Vomiting in Women Undergoing Breast Cancer Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2015-06-16
Enrollment: 187
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: Study Groups:

If you are eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. This is done because no one knows if one study group is better, the same, or worse than the other group.

If you are in Group 1, you will receive light electrical stimulation to the wrist area during surgery. You will also receive standard of care drugs to reduce PONV. If you have nausea or you are vomiting after surgery, you will receive additional standard of care drugs for those symptoms. You may ask the study staff for information about how the drugs are given and their risks.

If you are in Group 2, you will receive standard of care drugs to reduce PONV only (you will not receive electrical stimulation). If you have nausea or you are vomiting after surgery, you will receive additional standard of care drugs for those symptoms.

Electrical Stimulation:

The electrical stimulation is applied through a small sticky pad that is connected to a machine called a neuromuscular blockade monitor (NMBN). NMBNs are routinely used by anesthesiologists to monitor drug levels in muscles during surgery.

The pad will be placed on your wrist after you receive anesthesia and removed at the end of surgery so you will not know what group you are in.

Study Procedures:

Both Groups:

* You will have blood (about 2 teaspoons) collected intravenously (through your IV) during surgery. This blood will be used for genetic testing that may explain why people respond differently to treatments for nausea and vomiting.
* You will complete a questionnaire about your pre-treatment expectations and your nausea every 15 minutes after you wake up after surgery until you leave the clinic. It should take about 2-3 minutes to complete the questionnaire each time.

Length of Study:

Your participation in this study will be over once you leave the clinic after surgery.

This is an investigational study. The NMBM monitor is commercially available and FDA approved for use by anesthesiologists to monitor drug levels in the muscles during surgery. Its use in this study to control nausea/vomiting is investigational.

Up to 176 participants will be enrolled in this study. All will be enrolled at MD Anderson.

Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

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.

Primary outcomes:
measure: 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)
timeFrame: 1 day
Secondary outcomes:
measure: Feasibility of Intraoperative Neuromuscular Blockade Monitor (NMBM) During Surgery for Breast Cancer
timeFrame: 1 day
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Alicia M. Kowalski, MD
role: PRINCIPAL_INVESTIGATOR
References: