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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
188
Electrical stimulation to the wrist initiated at 1mHz, 1 pulse/second using two leads on a nerve stimulator. Stimulation continued throughout the breast surgery.
4 mg by vein for 1 dose.
10 mg by vein for 1 dose.
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
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"
Time frame: During stay in post-operative anesthesia care unit, until discharge, an average of 1 day
Feasibility of Conducting Study
Determine the study feasibility where feasibility is defined by at least 20% of screened patients meeting inclusion criteria ability, 50% of these patients consenting, and 75% of patients within the acupuncture study arm completing all procedures
Time frame: At study consent and at PACU discharge
Efficacy of Intervention to Prevent Need for Rescue Anti-emetics
Examine the effects of intra-operative NMBM stimulation of P6 on whether or not any anti-emetics were used compared to the control group
Time frame: During stay in post-operative anesthesia care unit, until discharge, an average of 1 day
Satisfaction
Examine group differences in post-operative patient satisfaction with PONV management. Participants were asked to rate their satisfaction with their nausea and vomiting management on a scale of 0-10, where "0" equals "very dissatisfied", and "10" equals "extremely satisfied".
Time frame: At discharge from post-operative anesthesia care unit
Efficacy of Intervention to Result in Decreased PACU Length-of-stay
Explore if intra-operative NMBM stimulation of P6 results in decreased PACU length-of-stay
Time frame: During stay in post-operative anesthesia care unit, until discharge, an average of 1 day
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6.25 mg by vein for 1 dose.
10 mg by vein for 1 dose.
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.
Expectancy
Explore the associations between expectancy and response to P6 stimulation. Step 1 of 2 compares expectancy answers between groups. The expectancy questionnaire asks participants what their expectation is of the effects of the intervention on lowering their nausea after surgery, lowering their pain after surgery, enabling them to cope with nausea and/or pain better, and enabling them to have a better recovery after surgery. Possible answers are "Not at all agree", "A little agree", "Moderately agree", "Mostly agree", and "Completely agree".
Time frame: Baseline
Expectancy and Response to P6 Stimulation
Explore the associations between expectancy and response to P6 stimulation. Step 2 of 2 compares baseline expectancy answers and response to P6 stimulation outcome directly, without taking into account group assignment. The P6 stimulation outcome was categorized as "Fail" or "Success", where "Success" is defined as "No nausea≥3 \& No vomiting \& No use of anti-emetic during PACU stay".
Time frame: During stay in post-operative anesthesia care unit, until discharge