Intraoperative Electrical Stimulation of the Acupoint P6 to Prevent Post-Operative Nausea and Vomiting in Women Undergoing Breast Cancer Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 188
- 试验地点
- 1
- 主要终点
- Efficacy of Intervention to Prevent Post-Operative Nausea and Vomiting (PONV)
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Electrical Stimulation + Standard of Care Antiemetics
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.
干预措施: Electrical Stimulation (Procedure)
Electrical Stimulation + Standard of Care Antiemetics
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.
干预措施: Zofran (Drug)
Electrical Stimulation + Standard of Care Antiemetics
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.
干预措施: Dexamethasone (Drug)
Electrical Stimulation + Standard of Care Antiemetics
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.
干预措施: Phenergan (Drug)
Electrical Stimulation + Standard of Care Antiemetics
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.
干预措施: Pepcid (Drug)
Electrical Stimulation + Standard of Care Antiemetics
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.
干预措施: Questionnaire (Behavioral)
Standard of Care Antiemetics
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.
干预措施: Zofran (Drug)
Standard of Care Antiemetics
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.
干预措施: Dexamethasone (Drug)
Standard of Care Antiemetics
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.
干预措施: Phenergan (Drug)
Standard of Care Antiemetics
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.
干预措施: Pepcid (Drug)
Standard of Care Antiemetics
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.
干预措施: Questionnaire (Behavioral)
结局指标
主要结局
Efficacy of Intervention to Prevent Post-Operative Nausea and Vomiting (PONV)
时间窗: During stay in post-operative anesthesia care unit, until discharge, an average of 1 day
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"
次要结局
- Feasibility of Conducting Study(At study consent and at PACU discharge)
- 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)
- 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)
- Expectancy(Baseline)
- Expectancy and Response to P6 Stimulation(During stay in post-operative anesthesia care unit, until discharge)